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\def\RunningAuthor{Naveenbabu Kilaru et al.}
\firstPage{2383}
\articleType{Original Article}
\receivedDate{05.09.2019}
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\journalVolume{2020, 11}
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\title{Assessment of Drug Utilization Pattern, Prevalence and Risk Factors for the Development of Diabetic Retinopathy among Type 2 Diabetic Patients in a South Indian Tertiary Care Hospital: a cross-sectional observational study}
\author{Madhavi~Mannam\textsuperscript{1},  
            Lavanya~Nalluri\textsuperscript{1},  
            Ravindrababu~Pingili\textsuperscript{2},  
            Jaidev~Sudagani\textsuperscript{3}, 
            Naveenbabu~Kilaru\textsuperscript{*}\textsuperscript{4}~\\[5pt]{\textsuperscript{1}Department of Pharmacy Practice, KVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada-520010, Andhra Pradesh, India}~\\{\textsuperscript{2}Department of Pharmacology, KVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada-520010, Andhra Pradesh, India}~\\{\textsuperscript{3}Endocrinologist, Santhi Endocrine and Diabetes Hospital, Vijayawada-520010, Andhra Pradesh, India}~\\{\textsuperscript{4}Department of Pharmaceutics and Pharmaceutical Biotechnology, KVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada-520010, Andhra Pradesh, India}}

\begin{abstract}
Diabetic retinopathy (DR) is a leading cause of visual impairment and blindness in the working-age population across the globe. The objective of the present study was to assess the drug utilization pattern, risk factors and prevalence of diabetic retinopathy in patients with type 2 diabetes mellitus in a south Indian tertiary care hospital. A cross-sectional observational study was conducted on 745 subjects (386 with diabetic retinopathy and 359 without diabetic retinopathy). Prevalence of diabetic retinopathy was measured and risk factors for the development of diabetic retinopathy were determined by calculating odds ratios using graph-pad prism statistical software and drug utilization pattern was assessed. Retinopathy was significantly higher in the subjects who are married, uneducated, housewives, urban residents, no income group and risk factors were comorbidities  HbA1c, high serum creatinine, duration of diabetes (5-10 years and {\textgreater}10 years), physical inactivity, junk foods (weekly once and weekly twice), soft drinks occasionally and tea/ coffee (daily twice). Metformin (38.21\%), combination of Insulin Isophane and Insulin Regular (16.75\%), Insulin Regular (15.18\%), combination of Glimepiride and Metformin (11.51\%), Glimepiride (7.85\%), combination of Metformin and Vildagliptin (7.85\%) were most commonly prescribed anti-diabetic drugs to the T2DM patients with retinopathy. 
\end{abstract}\def\keywordstitle{Keywords}

\begin{keywords}Type 2 diabetes,\newline Prevalence,\newline Risk factors,\newline Diabetic Retinopathy,\newline Metformin
\end{keywords}
\twocolumn[ \maketitle {\printKwdAbsBox}]
\makeatletter{\raggedright\textsuperscript{*}Corresponding Author\par Name:\ Naveenbabu~Kilaru~\\ Phone:\ +91- 9885589543,~\\  Email:\ naveenbabukvsr@gmail.com
        \par}\vspace*{-11pt}\hrulefill\par{\fontsize{12}{14}\selectfont ISSN: 0975-7538}\par% 
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\section{Introduction}
With 387 million people diagnosed with diabetes mellitus worldwide and a prevalence of 8.2\% as per the Diabetes atlas 2014, diabetes mellitus has become a global burden \unskip~\citep{767499:18253334,767499:18253331}. Diabetic retinopathy (DR) is a leading cause of visual impairment and blindness in the working-age population across the globe \unskip~\citep{767499:18253329,767499:18253335}. In 2010, of an estimated 285million people worldwide with diabetes, over one-third have signs of DR, and a third of these are afflicted with vision-threatening diabetic retinopathy (VTDR), defined as severe non-proliferative DR or proliferative DR (PDR) or the presence of diabetic macular edema (DME) \unskip~\citep{767499:18253333,767499:18253340}. Without treatment, 50\% of patients with proliferative diabetic retinopathy will become blind within 5 years \unskip~\citep{767499:18253338,767499:18253328}. The risk factors of DR can be broadly divided into modifiable and non-modifiable factors. The modifiable risk factors include hyperglycemia, hypertension, hyperlipidemia and obesity. In contrast, the duration of diabetes, puberty and pregnancy are the non-modifiable risk factors for DR development and progression \unskip~\citep{767499:18253343}.  The overall prevalence of DR and VTDR in T2DM was 34.6\% and 10.2\%, respectively. With the increasing number of people with diabetes, the number of DR and vision-threatening DR (VTDR), which includes severe non-proliferative DR, proliferative DR (PDR) and diabetic macular edema (DME), has been estimated to rise to 191.0 million and 56.3 million, respectively by 2030.

The World Health Organization (WHO) defines ``drug utilization'' as the marketing, distribution, prescription and use of the drugs in a society considering its medical, social, and economic consequences \unskip~\citep{767499:18253327}. Drug utilization studies help to assess whether the drug treatment is rational or not and to determine rational drug use, especially in poorer and rural populations \unskip~\citep{767499:18253342}. This study was conducted with an objective to screen the type 2 diabetes patients in order to determine the prevalence of diabetic retinopathy and to determine the risk factors that are responsible for the development of diabetic retinopathy and to assess the drug utilization pattern.
    
\section{Materials and Methods}
For this purpose, a cross-sectional observational study was carried out at the outpatient department of a tertiary care hospital by following the method developed by \unskip~\citep{767499:18253332}. The study was initiated after approval by the Institutes Ethical Review Committee. The protocol approval number was KVSRSCOPS/IEC/PG/231/2017.

\textbf{Selection of participants}

Patients of either sex diagnosed with or without T2DM of any duration (as per ADA guidelines) and willing to participate were included in the study. A total of 745 patients (359 patients with T2DM and 386 patients with diabetic retinopathy) were enrolled in the study.

\textbf{Inclusion criteria}

Patients of either sex diagnosed with type 2 diabetes mellitus of any duration, established as per American Diabetes Association (ADA) guidelines. Patients who are visiting a public endocrine hospital in six months would be recruited. 

\textbf{Exclusion criteria}

Patients with incomplete case reports. Patients having type 1 diabetes mellitus, gestational diabetes and maturity-onset diabetes of the young were excluded from the study. 

\textbf{Data collection}

Physicians were requested to report the clinical and biochemical data not exceeding 6 months before the observation. The information regarding demographics (age, sex), socioeconomic and lifestyle characteristics (smoking, alcohol consumption) was collected by interviewing the participant. Biochemical parameters were derived from the latest laboratory investigation reports documented in the clinical records. Socioeconomic status was assessed using the modified Kuppuswamy's scale, which considers the education qualification, occupation of the family head and family income per month of the participant. The diagnosis of diabetic retinopathy was made by an ophthalmologic examination that included fundoscopy or retinal photography and measurement of visual acuity, carried out by an ophthalmologist. All the relevant data were collected in a predesigned paper case record form with the prior consent of the participant. Data were collected from a total of 745 patients (359 patients with T2DM and 386 patients with diabetic retinopathy).

\textbf{Statistical Analysis}

In the descriptive statistical analysis, categorical variables were expressed as numbers and percentages. For categorical variables, the tests of significance analysis, we applied a Chi-Square test or Fisher Exact test. For all analysis, P{\textless}0.05 was regarded as statistically significant. The odds ratio with 95\% confidence intervals was calculated using univariate regression analysis. Data were analyzed using a statistical tool Graph pad prism software (version 5.0). 
    
\section{Results and Discussion}
A total of 745 subjects (359 with type 2 diabetes and 386 with diabetic retinopathy) were included in the study and the clinical characteristics of T2DM were presented in Table~\ref{tw-63065f5aafc8}. 


\begin{ThreePartTable}

\centering 
\begingroup
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\begin{TableNotes}\footnotesize 
    
\item{T2DM, Type 2 Diabetes Mellitus; BMI, Body Mass Index; HTN, Hypertension; CVDs, Cardiovascular Diseases; HbA1C, Glycated hemoglobin; HDL, High-DensityLipoproteins; LDL, Low-Density Lipo proteins}
\end{TableNotes}\setlength\LTcapwidth{\textwidth}
\begin{longtable}{p{\dimexpr.4996\linewidth-2\tabcolsep}p{\dimexpr.5004\linewidth-2\tabcolsep}}
\caption{\boldmath {Biochemical and clinical characteristics of patients with type 2 diabetes mellitus (N = 359)} }
\label{tw-63065f5aafc8}
\def\arraystretch{1.1}\\\endfirsthead \hline \noalign{\vskip3pt} \noalign{\textit{Table \thetable\ continued}} \noalign{\vskip3pt} \hline \endhead \hline \noalign{\vskip3pt} \noalign{\textit{\hfill Continued on next page}} \noalign{\vskip3pt} \endfoot \insertTableNotes \endlastfoot 
\tbltoprule \rowcolor{kwdboxcolor}Variable & Patients with T2DM N (\%)\\
\tblmidrule 
Gender &
  \\
Male &
  155 (43.2)\\
Female &
  204 (56.8)\\
Age &
  \\
0-20 years &
  0(0.3)\\
21-40 years &
  83 (23.2)\\
41-60 years &
  217 (60.6)\\
Above 60 years &
  57 (15.9)\\
Marital Status &
  \\
Unmarried  &
  16(4.5)\\
Married  &
  343(95.5)\\
Education  &
  \\
Un Educated &
  131(36.5)\\
Educated  &
  228(63.5)\\
BMI (Kg/m2) &
  \\
{\textless}25 Kg/m2 &
  114(31.8)\\
{\textgreater}25 Kg/m2 &
  245(68.2)\\
Body Weight (Kg) &
  \\
{\textless}50 &
  5(1.3)\\
50-70 &
  161(45)\\
{\textgreater}70 &
  192(53.6)\\
Nature of Work    &
  \\
Not working anywhere &
  41(11.4)\\
Private job &
  93(25.9)\\
Govt. job &
  39(10.8)\\
Daily labor &
  38(10.6)\\
Housewife &
  148(41.3)\\
Locality  &
  \\
Rural &
  105(29.2)\\
Urban &
  254(70.7)\\
Monthly Income  &
  \\
No income &
  170(47.5)\\
Below 25000 &
  115(32.1)\\
Above 25000 &
  73(20.4)\\
Co-morbidities &
  \\
No &
  131(29.4)\\
HTN &
  138(30.8)\\
History of CVDs &
  7(1.56)\\
Endocrine diseases &
  59(13.2)\\
Other  diseases &
  112(25.1)\\
HbA1C  &
  \\
{\textless}7 &
  141(44.2)\\
7-9 &
  109(34.2)\\
{\textgreater}9 &
  69(21.6)\\
Fasting Blood Glucose (mg/dL) &
  \\
70-80 &
  10(3)\\
80-120 &
  92(27.6)\\
121-160 &
  107(32)\\
161-200 &
  71(21.3)\\
{\textgreater}200 &
  54(16.2)\\
Post prandial blood glucose levels (mg/dL)  &
  \\
90-110 &
  3(1)\\
111-130 &
  9(3)\\
131-150 &
  33(10.9)\\
151-200 &
  165(54.6)\\
{\textgreater}200 &
  92(30.5)\\
Random Blood Glucose (mg/dL) &
  \\
80-100  &
  0\\
101-120 &
  0\\
121-140 &
  0\\
141-160 &
  2(13.3)\\
161-200 &
  1(6.7)\\
{\textgreater}200 &
  12(80)\\
HDL (mg/dL) &
  \\
Not available &
  54(20.1)\\
Normal &
  130(48.3)\\
Low &
  55(20.4)\\
High &
  30(11.2)\\
Triglycerides (mg/dL) &
  \\
Not available &
  54(20.5)\\
Normal &
  109(41.5)\\
Low &
  8(3)\\
High  &
  92(35)\\
Total Cholesterol (mg/dL) &
  \\
Not available &
  54(19.6)\\
Normal &
  151(54.7)\\
Low &
  6(2.2)\\
High &
  65(23.6)\\
LDL (mg/dL) &
  \\
Not available &
  57(20.8)\\
Normal &
  163(59.4)\\
Low &
  9(3.3)\\
High &
  45(16.5)\\
Urea (mg/dL) &
  \\
Not available &
  72(36.4)\\
Normal &
  78(39.4)\\
Low &
  0\\
High &
  48(24.2)\\
Serum creatinine (mg/dL) &
  \\
Not available &
  45(12.6)\\
Normal &
  305(85.2)\\
Low &
  5(1.4)\\
High &
  3(0.8)\\
Duration of T2DM (Years) &
  \\
{\textless}5 &
  172(47.9)\\
5-10     &
  111(30.9)\\
{\textgreater}10 &
  76(21.2)\\
Following T2DM education &
  \\
Yes &
  282(79.2)\\
No &
  74(20.8)\\
\tblbottomrule 
\end{longtable}
\endgroup
\end{ThreePartTable}

\makeatletter\@ifundefined{TwoColDocument}{}{\twocolumn}\makeatother 
Table~\ref{tw-b9572f15e09b} and Table~\ref{tw-76bf6f230996} shows the socio-demographic and lifestyle characteristics of subjects with and without diabetic retinopathy, respectively. The prevalence of diabetic retinopathy was significantly higher in the subjects who are married (98.2\%, P=0.0371), uneducated(69.9\%)patients, nature of work (housewives 47.6\%, P=0.0227), urban residents(60.6\% P=0.0037), no income group(65.5\%) and risk factors were comorbidities (other diseases 40.41\%, P{\textless}0.0001, HTN 31.1\%, P{\textless}0.0001, endocrine diseases 8.57\%, P=0.0223, history of CVDs 4.84\%, P\textless\ 0.0001), no physical activity(63.3\%), habit of taking junk foods (weekly once 19.9\%, weekly twice13.2\%, P{\textless}0.0001), soft drinks (occasionally 24.9\%, P=0.0073), tea/coffee(daily twice without sugar 38.1\%, P=0.0465),HbA1c(7-9\% 39.3\%, P=0.0018, {\textgreater}9\% 31.9\%, P{\textless}0.0001), high serum creatinine(14.8\%, P{\textless}0.0001), duration of diabetes (5-10 years 37.8\%, {\textgreater} 10 years 37.3\%, P{\textless}0.0001 ). Gender, age, BMI, body weight, monthly income, blood glucose levels, food habits, the habit of smoking, alcohol, stress levels are not significantly associated with the development of diabetic retinopathy.

Univariate regression analysis was performed to determine the odds ratios for the modifiable and non modifiable risk factors for T2DM (Table~\ref{tw-d81ba0014472}). The analysis showed that married (OR,2.526; 95\% CI,1.026 to 6.214, P=0.0371), poorly educated (OR,0.2468; 95\% CI,0.1818 to 0.3352, P{\textless}0.0001), house wives (OR,0.6068; 95\% CI,0.3941 to 0.9344, P=0.0227), urban residents (OR, 0.6364; 95\% CI, 0.4688-0.8639, P=0.0037) and risk factors were co-morbidities (other diseases (OR,4.650; 95\% CI,3.281 to 6.591, P{\textless}0.0001), hypertension (OR,2.642; 95\% CI,1.868 to 3.736, P{\textless}0.0001),Endocrine diseases (OR,1.685;95\% CI,1.075 to 2.641, P=0.0223), history of CVD (OR,8.117; 95\% CI,3.451 to 19.09, P{\textless}0.0001), duration of diabetes (5-10 years (OR, 2.357; 95\%CI, 1.659-3.348, P{\textless}0.0001 and with duration {\textgreater}10 years (OR, 3.395; 95\% CI, 2.336-4.933, P {\textless}0.0001), HbA1c (7-9\% OR,1.774;95\% CI,1.235 to 2.547, P=0.0018; {\textgreater}9\% OR, 2.275; 95\% CI,  1.529 to 3.386, P{\textless}0.0001), high serum creatinine  (OR, 11.55; 95\% CI,  3.415 to 39.10, P{\textless}0.0001), physical inactivity(OR,  0.5558;95\%CI,  0.4146 to 0.7450, P{\textless}0.0001), junk foods  weekly once (OR,3.287; 95\% CI, 2.049 to 5.274, P{\textless}0.0001) and weekly twice (OR,2.935; 95\% CI, 1.709 to 5.038, P{\textless}0.0001), soft drinks occasionally (OR,1.642; 95\% CI, 1.141 to 2.364, P=0.0073), tea/ coffee(daily twice without sugar OR,1.598; 95\% CI, 1.006 to 2.539, P=0.0465).

The drug utilization pattern was assessed and presented the results in Table~\ref{tw-9b38d0ea9d4b}. Metformin (38.21\%), combination of Insulin Isophane and Insulin Regular (16.75\%), Insulin Regular (15.18\%), combination of Glimepiride and Metformin (11.51\%), Glimepiride (7.85\%), combination of Metformin and Vildagliptin (7.85\%) were most commonly prescribed anti-diabetic drugs to the T2DM patients with retinopathy. The present study's results suggested that subjects who are married, uneducated patients, nature of work (housewives), urban residents, no income group and risk factors were comorbidities(other diseases, HTN, endocrine diseases, history of CVDs), no physical activity, habit of taking junk foods (weakly once, weakly twice), soft drinks (occasionally), tea/coffee(daily twice without sugar), poor glycemic control, high serum creatinine, duration of diabetes are major risk factors for the development of retinopathy complication.

\textbf{Marital status}

The present study's results revealed that marital status (98.2\%, P=0.0371) was significantly associated and was the major risk factor for diabetic retinopathy (OR, 2.526; 95\% CI, 1.026 {\textendash} 6.214). Therefore, further studies are needed to evaluate the exact impact of marital status on risk for diabetic retinopathy.

\textbf{Education}

Education is one of the risk factors for the development of diabetic retinopathy. \unskip~\citep{767499:18253336} conducted a study on Prevalence and risk factors for diabetic retinopathy at diagnosis (DRAD) in patients recently diagnosed with type 2 diabetes (T2D) or latent autoimmune diabetes in the adult (LADA) and concluded that DRAD prevalence in patients recently diagnosed with T2DM or is 12\%. Low educational levels and low beta-cell function at diagnosis are risk factors for DRAD \unskip~\citep{767499:18253336}. The present study's results also supported that educational status was significantly associated with (69.9\%, P {\textless}0.0001) and a risk factor for the development of diabetic retinopathy.

\textbf{Nature of work }

The present study's results revealed that housewives (47.6\%, P=0.0227) were significantly associated and was the major risk factor for diabetic retinopathy (OR, 0.6068; 95\% CI, 0.3941-0.9344). Therefore, further studies are needed to evaluate the exact impact of the nature of work on risk for diabetic retinopathy.

\textbf{Urban residence}

The present study's results revealed that urban residents (60.6\%, P=0.0037) were significantly associated and was the major risk factor for diabetic retinopathy (OR, 0.6364; 95\% CI, 0.4688-0.8639). 


\begin{ThreePartTable}

\centering 
\begingroup
\makeatletter\if@twocolumn\@ifundefined{theposttbl}{\gdef\TwoColDocument{true}\onecolumn\onecolumn}{}\fi\makeatother 
\begin{TableNotes}\footnotesize 
    
\item{T2DM, Type 2 Diabetes Mellitus; BMI, Body Mass Index; HTN, Hypertension; CVDs, Cardiovascular Diseases; HbA1C, Glycated hemoglobin; HDL, High-DensityLipoproteins; LDL, Low-Density Lipoproteins}
\end{TableNotes}\setlength\LTcapwidth{\textwidth}
\begin{longtable}{p{\dimexpr.2029\linewidth-2\tabcolsep}p{\dimexpr.2781\linewidth-2\tabcolsep}p{\dimexpr.2011999999999999\linewidth-2\tabcolsep}p{\dimexpr.31779999999999998\linewidth-2\tabcolsep}}
\caption{\boldmath {Socio-demographic characteristics of diabetic } patients with (N=254) or without diabetic retinopathy (N= 359)}
\label{tw-b9572f15e09b}
\def\arraystretch{1.1}\\\endfirsthead \hline \noalign{\vskip3pt} \noalign{\textit{Table \thetable\ continued}} \noalign{\vskip3pt} 
\tbltoprule \rowcolor{kwdboxcolor} &  &  & \\
\rowcolor{kwdboxcolor}Variable & Patients with T2DM N (\%) & Patients with T2DM and retinopathy  \mbox{}\protect\newline N (\%) \mbox{}\protect\newline  & P-Value\\
\tblmidrule \endhead \hline \noalign{\vskip3pt} \noalign{\textit{\hfill Continued on next page}} \noalign{\vskip3pt} \endfoot \insertTableNotes \endlastfoot 
\tbltoprule \rowcolor{kwdboxcolor} &  &  & \\
\rowcolor{kwdboxcolor}Variable & Patients with T2DM N (\%) & Patients with T2DM and retinopathy  \mbox{}\protect\newline N (\%) \mbox{}\protect\newline  & P-Value\\
\tblmidrule 
Gender &
   &
   &
  \\
Male &
  155 (43.2) &
  99 (39) &
  Ref\\
Female &
  204 (56.8) &
  155 (61) &
  0.2985\\
Age  &
   &
   &
  \\
 0-20 years &
  1 (0.3) &
  -- &
  Ref\\
21-40 years &
  83 (23.2) &
  20 (7.9) &
  0.6239\\
 41-60 years &
  217 (60.6) &
  152 (59.8) &
  0.4031\\
 Above 60 years &
  57 (15.9) &
  82 (32.3) &
  0.2328\\
Marital Status &
   &
   &
  \\
Unmarried &
  16 (4.5) &
  3 (1.2) &
  Ref\\
Married  &
  343 (95.5) &
  251 (98.8) &
  0.0211*\\
Education  &
   &
   &
  \\
 Un Educated  &
  131 (36.5) &
  155 (61) &
  Ref\\
 Educated  &
  228 (63.5) &
  99 (39) &
  {\textless}0.0001***\\
BMI (Kg/m\ensuremath{^{2}}) &
   &
   &
  \\
 {\textless}25 Kg/m\ensuremath{^{2}} \mbox{}\protect\newline  {\textgreater}/=25 Kg &
  114 (31.8) \mbox{}\protect\newline 245 (68.2) &
  62 (24.5) \mbox{}\protect\newline 191 (75.5) &
  Ref \mbox{}\protect\newline 0.0511\\
Body Weight (Kg) &
   &
   &
  \\
 {\textless}50 \mbox{}\protect\newline  50-70 \mbox{}\protect\newline  {\textgreater}70 &
  5 (1.3) \mbox{}\protect\newline 161 (45) \mbox{}\protect\newline 192 (53.7) &
  5 (2) \mbox{}\protect\newline 112 (44.3) \mbox{}\protect\newline 136 (53.7) &
  Ref \mbox{}\protect\newline 0.5714 \mbox{}\protect\newline 0.5897\\
Nature of Work &
   &
   &
  \\
Not working anywhere  &
  41 (11.4) &
  57 (22.5) &
  Ref\\
Private job \mbox{}\protect\newline Govt. job \mbox{}\protect\newline Daily labour \mbox{}\protect\newline Housewife  &
  93 (25.9) \mbox{}\protect\newline 39 (10.8) \mbox{}\protect\newline 38 (10.6) \mbox{}\protect\newline 148 (41.2) &
  45 (17.7) \mbox{}\protect\newline 14 (5.5) \mbox{}\protect\newline 25 (9.8) \mbox{}\protect\newline 113 (44.4) &
  {\textless}0.0001*** \mbox{}\protect\newline 0.0002*** \mbox{}\protect\newline 0.0221* \mbox{}\protect\newline 0.0120*\\
Locality  &
   &
   &
  \\
 Rural  \mbox{}\protect\newline  Urban &
  105 (29.2) \mbox{}\protect\newline 254 (70.8) &
  130 (51.2) \mbox{}\protect\newline 124 (48.8) &
  Ref \mbox{}\protect\newline {\textless}0.0001***\\
Monthly Income  &
   &
   &
  \\
 No income \mbox{}\protect\newline  Below 25000 \mbox{}\protect\newline  Above 25000  &
  170 (47.5) \mbox{}\protect\newline 115 (32.1) \mbox{}\protect\newline 73 (20.4) &
  148 (58.3) \mbox{}\protect\newline 87 (34.2) \mbox{}\protect\newline 19 (7.4) &
  Ref \mbox{}\protect\newline 0.4382 \mbox{}\protect\newline {\textless}0.0001***\\
Co-morbidities &
   &
   &
  \\
 No  \mbox{}\protect\newline  HTN &
  131 (29.4) \mbox{}\protect\newline 138 (30.8) &
  37 (8.6) \mbox{}\protect\newline 161 (37.44) &
  Ref \mbox{}\protect\newline {\textless}0.0001***\\
History of CVDs &
  7 (1.56) &
  34 (7.90) &
  {\textless}0.0001***\\
Endocrine diseases &
  59 (13.2) &
  41 (9.53) &
  0.0009***\\
Other diseases &
  112 (25.1) &
  157 (36.51) &
  {\textless}0.0001***\\
Systolic Blood Pressure &
   &
   &
  \\
 {\textless}140 mmHg \mbox{}\protect\newline  {\textgreater}/=140 mmHg &
  259 (72.1) \mbox{}\protect\newline 100 (27.9) &
  160 (63) \mbox{}\protect\newline 94 (37) &
  Ref \mbox{}\protect\newline 0.0164*\\
Diastolic Blood Pressure &
   &
   &
  \\
 {\textless}90 mmHg \mbox{}\protect\newline  {\textgreater}/=90 mmHg &
  281 (78.3) \mbox{}\protect\newline 78 (21.7) &
  203 (79.9) \mbox{}\protect\newline 51 (20) &
  Ref \mbox{}\protect\newline 0.6219\\
HbA1C  &
   &
   &
  \\
 {\textless}7 \mbox{}\protect\newline  7-9 \mbox{}\protect\newline  {\textgreater}9 &
  141 (44.2) \mbox{}\protect\newline 109 (34.2) \mbox{}\protect\newline 69 (21.6) &
  52 (21.8) \mbox{}\protect\newline 100 (42) \mbox{}\protect\newline 86 (36.1) &
  Ref \mbox{}\protect\newline {\textless}0.0001*** \mbox{}\protect\newline {\textless}0.0001***\\
Fasting Blood Glucose (mg/dL) &
   &
   &
  \\
 70-80 \mbox{}\protect\newline  80-120 \mbox{}\protect\newline  121-160 \mbox{}\protect\newline  161-200 \mbox{}\protect\newline  {\textgreater}200 &
  10 (3) \mbox{}\protect\newline 92 (27.6) \mbox{}\protect\newline 107 (32) \mbox{}\protect\newline 71 (21.3) \mbox{}\protect\newline 54 (16.2) &
  2 (0.9) \mbox{}\protect\newline 54 (24) \mbox{}\protect\newline 62 (27.6) \mbox{}\protect\newline 41 (18.2) \mbox{}\protect\newline 66 (29.3) &
  Ref \mbox{}\protect\newline 0.1572 \mbox{}\protect\newline 0.1610 \mbox{}\protect\newline 0.1678 \mbox{}\protect\newline 0.0113*\\
Post prandial blood glucose levels (mg/dL) &
   &
   &
  \\
 90-110 \mbox{}\protect\newline  111-130 \mbox{}\protect\newline  131-150 \mbox{}\protect\newline  151-200 \mbox{}\protect\newline  {\textgreater}200 &
  3 (1) \mbox{}\protect\newline 9 (3) \mbox{}\protect\newline 33 (10.9) \mbox{}\protect\newline 165 (54.6) \mbox{}\protect\newline 92 (30.5) &
  1 (0.5) \mbox{}\protect\newline 5 (2.3) \mbox{}\protect\newline 12 (5.6) \mbox{}\protect\newline 98 (45.4) \mbox{}\protect\newline 100 (46.3) &
  0.6885 \mbox{}\protect\newline 0.9423 \mbox{}\protect\newline 0.6143 \mbox{}\protect\newline 0.2834 \mbox{}\protect\newline Ref\\
Random Blood Glucose (mg/dL) \mbox{}\protect\newline  &
   &
   &
  \\
 80-100  \mbox{}\protect\newline  101-120  \mbox{}\protect\newline  121-140 \mbox{}\protect\newline  141-160 \mbox{}\protect\newline  161-200 \mbox{}\protect\newline  {\textgreater}200 &
  0 \mbox{}\protect\newline 0 \mbox{}\protect\newline 0 \mbox{}\protect\newline 2 (13.3) \mbox{}\protect\newline 1 (6.7) \mbox{}\protect\newline 12 (80) &
  4 (5.2) \mbox{}\protect\newline 5 (6.5) \mbox{}\protect\newline 2 (2.6) \mbox{}\protect\newline 8 (10.4) \mbox{}\protect\newline 9 (11.7) \mbox{}\protect\newline 49 (63.6) &
  0.3259 \mbox{}\protect\newline 0.2729 \mbox{}\protect\newline 0.4857 \mbox{}\protect\newline 0.9807 \mbox{}\protect\newline 0.4635 \mbox{}\protect\newline Ref\\
HDL (mg/dL) \mbox{}\protect\newline  &
   &
   &
  \\
 Not available  \mbox{}\protect\newline  Normal \mbox{}\protect\newline  Low \mbox{}\protect\newline  High &
  54 (20.1) \mbox{}\protect\newline 130 (48.3) \mbox{}\protect\newline 55 (20.4) \mbox{}\protect\newline 30 (11.2) &
  84 (37.8) \mbox{}\protect\newline 73 (32.9) \mbox{}\protect\newline 51 (23) \mbox{}\protect\newline 14 (6.4) &
  Ref \mbox{}\protect\newline {\textless}0.0001*** \mbox{}\protect\newline 0.0470* \mbox{}\protect\newline 0.0008***\\
Triglycerides (mg/dL) &
   &
   &
  \\
 Not available  &
  54 (20.5) &
  85 (38.5) &
  Ref\\
 Normal \mbox{}\protect\newline  Low  \mbox{}\protect\newline  High  &
  109 (41.5) \mbox{}\protect\newline 8 (3) \mbox{}\protect\newline 92 (35) &
  46 (20.8) \mbox{}\protect\newline 2 (0.9) \mbox{}\protect\newline 88 (39.8) &
  {\textless}0.0001*** \mbox{}\protect\newline 0.0108* \mbox{}\protect\newline 0.0293*\\
Total Cholesterol (mg/dL) &
   &
   &
  \\
 Not available  &
  54 (19.6) &
  82 (36.8) &
  Ref\\
 Normal \mbox{}\protect\newline  Low \mbox{}\protect\newline  High &
  151 (54.7) \mbox{}\protect\newline 6 (2.2) \mbox{}\protect\newline 65 (23.6) &
  78 (35) \mbox{}\protect\newline 1 (0.4) \mbox{}\protect\newline 62 (27.8) &
  {\textless}0.0001*** \mbox{}\protect\newline 0.0161* \mbox{}\protect\newline 0.0617\\
LDL (mg/dL) &
   &
   &
  \\
 Not available  &
  57 (20.8) &
  82 (37.1) &
  Ref\\
 Normal \mbox{}\protect\newline  Low \mbox{}\protect\newline  High &
  163 (59.4) \mbox{}\protect\newline 9 (3.3) \mbox{}\protect\newline 45 (16.5) &
  71 (32.2) \mbox{}\protect\newline 4 (1.8) \mbox{}\protect\newline 64 (28.9) &
  {\textless}0.0001*** \mbox{}\protect\newline 0.0496* \mbox{}\protect\newline 0.9649\\
Urea (mg/dL)  &
   &
   &
  \\
Not available  &
  72 (36.4) &
  120 (59.1) &
  Ref\\
  Normal \mbox{}\protect\newline  Low  \mbox{}\protect\newline  High &
  78 (39.4) \mbox{}\protect\newline 0 \mbox{}\protect\newline 48 (24.2) &
  22 (10.8) \mbox{}\protect\newline 0 \mbox{}\protect\newline 61 (30.1) &
  {\textless}0.0001*** \mbox{}\protect\newline ----- \mbox{}\protect\newline 0.2656\\
Serum creatinine (mg/dL) &
   &
   &
  \\
Not available &
  45 (12.6) &
  7 (2.8) &
  Ref\\
  Normal \mbox{}\protect\newline  Low \mbox{}\protect\newline  High  &
  305 (85.2) \mbox{}\protect\newline 5 (1.4) \mbox{}\protect\newline 3 (0.8) &
  175 (68.9) \mbox{}\protect\newline 0 \mbox{}\protect\newline 72 (28.3) &
  0.0009*** \mbox{}\protect\newline 0.3811 \mbox{}\protect\newline {\textless}0.0001***\\
Duration of T2DM (Years) &
   &
   &
  \\
 {\textless}5 &
  172 (47.9) &
  59 (23.2) &
  Ref\\
 5-10 &
  111 (30.9) &
  101(39.8) &
  {\textless}0.0001***\\
 {\textgreater}10 &
  76 (21.2) &
  94 (37) &
  {\textless}0.0001***\\
Following T2DM education &
   &
   &
  \\
 Yes  &
  282 (79.2) &
  180 (70.9) &
  Ref\\
 No &
  74 (20.8) &
  74 (29.1) &
  0.0177*\\
 &
   &
   &
  \\
\tblbottomrule 
\end{longtable}
\endgroup
\end{ThreePartTable}

\makeatletter\@ifundefined{TwoColDocument}{}{\twocolumn}\makeatother 

\begin{table*}[!htbp]
\caption{\boldmath {Food and lifestyle characteristics of diabetic patients with (N=254) or without diabetic retinopathy (N=359).} }
\label{tw-76bf6f230996}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.269\linewidth-2\tabcolsep}p{\dimexpr.2638\linewidth-2\tabcolsep}p{\dimexpr.24830000000000005\linewidth-2\tabcolsep}p{\dimexpr.2189\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}Variable & Patients with T2DM \mbox{}\protect\newline N (\%) & Patients with T2DM and retinopathy \mbox{}\protect\newline N (\%) & P-value\\
\tblmidrule 
Food habits &
   &
   &
  \\
Vegetariam \mbox{}\protect\newline Mixed &
  60 (16.7) \mbox{}\protect\newline 299 (83.3) &
  37 (14.6) \mbox{}\protect\newline 217 (85.4) &
  Ref \mbox{}\protect\newline 0.4732\\
Physical activity &
   &
   &
  \\
No physical activity &
  176 (49) &
  165 (64.9) &
  Ref\\
Regular exercise &
  183 (50.9) &
  89 (35) &
  {\textless}0.0001***\\
\multicolumn{2}{p{\dimexpr(.5328\linewidth-2\tabcolsep)}}{Habit of smoking} &
   &
  \\
 No \mbox{}\protect\newline  Yes \mbox{}\protect\newline  Past smoker &
  320 (89.1) \mbox{}\protect\newline 22 (6.1) \mbox{}\protect\newline 17 (4.7) &
  218 (85.8) \mbox{}\protect\newline 18 (7.1) \mbox{}\protect\newline 18 (7.1) &
  Ref \mbox{}\protect\newline 0.5781 \mbox{}\protect\newline 0.2039\\
\multicolumn{2}{p{\dimexpr(.5328\linewidth-2\tabcolsep)}}{The habit of drinking alcohol } &
   &
  \\
 No \mbox{}\protect\newline  Yes \mbox{}\protect\newline  Past alcoholic &
  304 (85.1) \mbox{}\protect\newline 44 (12.3) \mbox{}\protect\newline 9 (2.5) &
  221 (87) \mbox{}\protect\newline 25 (9.9) \mbox{}\protect\newline 8 (3.2) &
  Ref \mbox{}\protect\newline 0.3526 \mbox{}\protect\newline 0.6834\\
\multicolumn{2}{p{\dimexpr(.5328\linewidth-2\tabcolsep)}}{The habit of taking junk foods } &
   &
  \\
 No \mbox{}\protect\newline Weekly once \mbox{}\protect\newline Weekly twice &
  180 (50.3) \mbox{}\protect\newline 31 (8.7) \mbox{}\protect\newline 23 (6.4) &
  123 (48.6) \mbox{}\protect\newline 16 (6.3) \mbox{}\protect\newline 18 (7.1) &
  Ref \mbox{}\protect\newline 0.3931 \mbox{}\protect\newline 0.6860\\
Weekly thrice and more &
  28 (7.8) &
  23 (9.1) &
  0.5455\\
Occasionally &
  96 (26.8) &
  73 (28.9) &
  0.5824\\
\multicolumn{2}{p{\dimexpr(.5328\linewidth-2\tabcolsep)}}{The habit of taking fruits /fruit juices } &
   &
  \\
No \mbox{}\protect\newline Weekly once \mbox{}\protect\newline Weekly twice \mbox{}\protect\newline Weekly thrice \& more &
  66 (18.5) \mbox{}\protect\newline 27 (7.5) \mbox{}\protect\newline 35 (9.8) \mbox{}\protect\newline 125 (34.9) &
  62 (24.5) \mbox{}\protect\newline 17 (6.7) \mbox{}\protect\newline 22 (8.7) \mbox{}\protect\newline 57 (22.4) &
  Ref \mbox{}\protect\newline 0.2604 \mbox{}\protect\newline 0.2145 \mbox{}\protect\newline 0.0023**\\
Occasionally &
  105 (29.3) &
  96 (37.8) &
  0.9047\\
\multicolumn{2}{p{\dimexpr(.5328\linewidth-2\tabcolsep)}}{The habit of taking soft drinks } &
   &
  \\
No \mbox{}\protect\newline Weekly once \mbox{}\protect\newline Weekly twice \mbox{}\protect\newline Weekly thrice \& more &
  272 (76.2) \mbox{}\protect\newline 6 (1.7) \mbox{}\protect\newline 5 (1.4) \mbox{}\protect\newline 14 (4) &
  163 (64.1) \mbox{}\protect\newline 6 (2.4) \mbox{}\protect\newline 2 (0.8) \mbox{}\protect\newline 2 (0.8) &
  Ref \mbox{}\protect\newline 0.3773 \mbox{}\protect\newline 0.6291 \mbox{}\protect\newline 0.0417* \mbox{}\protect\newline \\
Occasionally &
  60 (16.8) &
  81 (31.9) &
  {\textless}0.0001***\\
\multicolumn{2}{p{\dimexpr(.5328\linewidth-2\tabcolsep)}}{The habit of taking tea/coffee } &
   &
  \\
 No &
  55 (15.3) &
  29 (11.5) &
  Ref\\
Daily once without sugar &
  54 (15) &
  32 (12.6) &
  0.7151\\
Daily twice without sugar &
  110 (30.6) &
  107 (42.3) &
  0.0208*\\
Daily thrice without sugar &
  58 (16.2) &
  35 (13.9) &
  0.6671\\
Daily once with sugar &
  25 (6.9) &
  16 (6.3) &
  0.6226\\
Daily twice with sugar &
  37 (10.3) &
  24 (9.5) &
  0.5518\\
Daily thrice with sugar &
  20 (5.6) &
  10 (4) &
  0.9061\\
\multicolumn{2}{p{\dimexpr(.5328\linewidth-2\tabcolsep)}}{Situations at working places} &
   &
  \\
No stress &
  181 (50.4) &
  127 (50) &
  Ref\\
Stress &
  178 (49.6) &
  127 (50) &
  0.9188\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{ThreePartTable}

\centering 
\begingroup
\makeatletter\if@twocolumn\@ifundefined{theposttbl}{\gdef\TwoColDocument{true}\onecolumn\onecolumn}{}\fi\makeatother 
\begin{TableNotes}\footnotesize 
    
\item{T2DM, Type 2 Diabetes Mellitus; BMI, Body Mass Index; HTN, Hypertension; CVDs, Cardiovascular Diseases; HbA1C, Glycated hemoglobin; HDL, High-Density Lipoproteins; LDL, Low-Density Lipoproteins}
\end{TableNotes}\setlength\LTcapwidth{\textwidth}
\begin{longtable}{p{\dimexpr.3456\linewidth-2\tabcolsep}p{\dimexpr.33519999999999996\linewidth-2\tabcolsep}p{\dimexpr.3192\linewidth-2\tabcolsep}}
\caption{\boldmath {Univariate regression analysis of modifiable and non-modifiable risk factors for the developmentof retinopathy in patients with type 2 diabetes mellitus} }
\label{tw-d81ba0014472}
\def\arraystretch{1.1}\\\endfirsthead \hline \noalign{\vskip3pt} \noalign{\textit{Table \thetable\ continued}} \noalign{\vskip3pt} 
\tbltoprule \rowcolor{kwdboxcolor}Variable & OR (95\% CI) & P-value \\
\tblmidrule \endhead \hline \noalign{\vskip3pt} \noalign{\textit{\hfill Continued on next page}} \noalign{\vskip3pt} \endfoot \insertTableNotes \endlastfoot 
\tbltoprule \rowcolor{kwdboxcolor}Variable & OR (95\% CI) & P-value \\
\tblmidrule 
Gender &
   &
  \\
 Male \mbox{}\protect\newline  Female &
  1 \mbox{}\protect\newline 1.190 (0.8574 to 1.651) &
  Ref \mbox{}\protect\newline 0.2985\\
Age  &
   &
  \\
 0-20 years  \mbox{}\protect\newline  21-40 years \mbox{}\protect\newline  41-60 years \mbox{}\protect\newline  Above 60 years &
  1 \mbox{}\protect\newline 0.7365 (0.02891 to 18.76) \mbox{}\protect\newline 2.103 (0.08505 to 52.02) \mbox{}\protect\newline 4.304 (0.1721 to 107.6) &
  Ref \mbox{}\protect\newline 0.6239 \mbox{}\protect\newline 0.4031 \mbox{}\protect\newline 0.2328\\
Marital Status &
   &
  \\
Unmarried \mbox{}\protect\newline Married  &
  1 \mbox{}\protect\newline 3.903 (1.125 to 13.54) &
  Ref \mbox{}\protect\newline 0.0211*\\
Education  &
   &
  \\
Uneducated Educated  &
  1 \mbox{}\protect\newline 0.3670 (0.2635 to 0.5112) &
  Ref \mbox{}\protect\newline {\textless}0.0001***\\
BMI (Kg/m2) &
   &
  \\
{\textless}25 Kg/m2 \mbox{}\protect\newline {\textgreater}/=25 Kg/m2 &
  1 \mbox{}\protect\newline 1.433 (0.9974 to 2.060) &
  Ref \mbox{}\protect\newline 0.0511\\
Body Weight (Kg) &
   &
  \\
{\textless}50 \mbox{}\protect\newline 50-70 \mbox{}\protect\newline {\textgreater}70 &
  1 \mbox{}\protect\newline 0.6957 (0.1967 to 2.460) \mbox{}\protect\newline 0.7083 (0.2011 to 2.495) &
  Ref \mbox{}\protect\newline 0.5714 \mbox{}\protect\newline 0.5897\\
Nature of Work &
   &
  \\
Not working anywhere  &
  1 &
  Ref\\
Private job \mbox{}\protect\newline Govt. job \mbox{}\protect\newline Daily labour \mbox{}\protect\newline Housewife  &
  0.3480 (0.2035 to 0.5952) \mbox{}\protect\newline 0.2582 (0.1243 to 0.5363) \mbox{}\protect\newline 0.4732 (0.2483 to 0.9020) \mbox{}\protect\newline 0.5492 (0.3432 to 0.8789) &
  {\textless}0.0001*** \mbox{}\protect\newline 0.0002*** \mbox{}\protect\newline 0.0221* \mbox{}\protect\newline 0.0120*\\
Locality  &
   &
  \\
 Rural  \mbox{}\protect\newline  Urban &
  1 \mbox{}\protect\newline 0.3943 (0.2820 to 0.5513) &
  Ref \mbox{}\protect\newline {\textless}0.0001***\\
Monthly Income  &
   &
  \\
No income \mbox{}\protect\newline Below 25000 \mbox{}\protect\newline Above 25000 &
  1 \mbox{}\protect\newline 0.8690 (0.6092 to 1.240) \mbox{}\protect\newline 0.2990 (0.1723 to 0.5187) &
  Ref \mbox{}\protect\newline 0.4382 \mbox{}\protect\newline {\textless}0.0001***\\
Co-morbidities &
   &
  \\
No  \mbox{}\protect\newline HTN \mbox{}\protect\newline History of CVDs \mbox{}\protect\newline Endocrine diseases \mbox{}\protect\newline Other diseases &
  1 \mbox{}\protect\newline 4.131 (2.687 to 6.350) \mbox{}\protect\newline 17.20 (7.049 to 41.95) \mbox{}\protect\newline 2.460 (1.433 to 4.224) \mbox{}\protect\newline 4.963 (3.202 to 7.692) &
  Ref \mbox{}\protect\newline {\textless}0.0001*** \mbox{}\protect\newline {\textless}0.0001*** \mbox{}\protect\newline 0.0009*** \mbox{}\protect\newline {\textless}0.0001***\\
\multicolumn{2}{p{\dimexpr(.6808\linewidth-2\tabcolsep)}}{Systolic Blood Pressure} &
  \\
{\textless}140 mmHg \mbox{}\protect\newline {\textgreater}140 mmHg &
  1 \mbox{}\protect\newline 1.522 (1.079 to 2.146) &
  Ref \mbox{}\protect\newline 0.0164*\\
\multicolumn{2}{p{\dimexpr(.6808\linewidth-2\tabcolsep)}}{Diastolic Blood Pressure} &
  \\
{\textless}90mmHg \mbox{}\protect\newline {\textgreater}90mmHg &
  1 \mbox{}\protect\newline 0.9051 (0.6088 to 1.346) &
  Ref \mbox{}\protect\newline 0.6219\\
HbA1C &
   &
  \\
{\textless}7 \mbox{}\protect\newline 7-9 \mbox{}\protect\newline {\textgreater}9 &
  1 \mbox{}\protect\newline 2.488 (1.638 to 3.779) \mbox{}\protect\newline 3.380 (2.157 to 5.295) &
  Ref \mbox{}\protect\newline {\textless}0.0001*** \mbox{}\protect\newline {\textless}0.0001***\\
\multicolumn{2}{p{\dimexpr(.6808\linewidth-2\tabcolsep)}}{Fasting Blood Glucose (mg/dL)} &
  \\
70-80 \mbox{}\protect\newline 81-120 \mbox{}\protect\newline 121-160 \mbox{}\protect\newline 161-200 \mbox{}\protect\newline {\textgreater}200 &
  1 \mbox{}\protect\newline 2.935 (0.6196 to 13.90) \mbox{}\protect\newline 2.897 (0.6146 to 13.66) \mbox{}\protect\newline 2.887 (0.6028 to 13.83) \mbox{}\protect\newline 6.111 (1.283 to 29.10) &
  Ref \mbox{}\protect\newline 0.1572 \mbox{}\protect\newline 0.1610 \mbox{}\protect\newline 0.1678 \mbox{}\protect\newline 0.0113*\\
\multicolumn{2}{p{\dimexpr(.6808\linewidth-2\tabcolsep)}}{Post prandial blood glucose levels (mg/dL)} &
  \\
90-110 \mbox{}\protect\newline 111-130 \mbox{}\protect\newline 131-150 \mbox{}\protect\newline 151-200 \mbox{}\protect\newline {\textgreater}200 &
  1 \mbox{}\protect\newline 1.667 (0.1349 to 20.59) \mbox{}\protect\newline 1.091 (0.1032 to 11.53) \mbox{}\protect\newline 1.782 (0.1827 to 17.38) \mbox{}\protect\newline 3.261 (0.3331 to 31.92) &
  Ref \mbox{}\protect\newline 0.6885 \mbox{}\protect\newline 0.9423 \mbox{}\protect\newline 0.6143 \mbox{}\protect\newline 0.2834\\
\multicolumn{2}{p{\dimexpr(.6808\linewidth-2\tabcolsep)}}{Random Blood Glucose (mg/dL)} &
  \\
80-100  \mbox{}\protect\newline 101-120  \mbox{}\protect\newline 121-140 \mbox{}\protect\newline 141-160 \mbox{}\protect\newline 161-200 \mbox{}\protect\newline {\textgreater}200 &
  2.273 (0.1146 to 45.09) \mbox{}\protect\newline 2.778 (0.1437 to 53.69) \mbox{}\protect\newline 1.263 (0.05689 to 28.02) \mbox{}\protect\newline 0.9796 (0.1837 to 5.222) \mbox{}\protect\newline 2.204 (0.2540 to 19.13) \mbox{}\protect\newline 1 &
  0.3259 \mbox{}\protect\newline 0.2729 \mbox{}\protect\newline 0.4857 \mbox{}\protect\newline 0.9807 \mbox{}\protect\newline 0.4635 \mbox{}\protect\newline Ref\\
HDL (mg/dL) &
   &
  \\
Not available  \mbox{}\protect\newline Normal \mbox{}\protect\newline Low \mbox{}\protect\newline High &
  1 \mbox{}\protect\newline 0.3610 (0.2310 to 0.5640) \mbox{}\protect\newline 0.5961 (0.3572 to 0.9947) \mbox{}\protect\newline 0.3000 (0.1459 to 0.6168) &
  Ref \mbox{}\protect\newline {\textless}0.0001*** \mbox{}\protect\newline 0.0470* \mbox{}\protect\newline 0.0008***\\
Triglycerides (mg/dL) &
   &
  \\
Not available \mbox{}\protect\newline Normal \mbox{}\protect\newline Low \mbox{}\protect\newline High  &
  1 \mbox{}\protect\newline 0.2681 (0.1651 to 0.4354) \mbox{}\protect\newline 0.1588 (0.03249 to0.7765) \mbox{}\protect\newline 0.6077 (0.3878 to 0.9523) &
  Ref \mbox{}\protect\newline {\textless}0.0001*** \mbox{}\protect\newline 0.0108* \mbox{}\protect\newline 0.0293*\\
\multicolumn{2}{p{\dimexpr(.6808\linewidth-2\tabcolsep)}}{Total Cholesterol (mg/dL)} &
  \\
Not available  \mbox{}\protect\newline Normal \mbox{}\protect\newline Low \mbox{}\protect\newline High &
  1 \mbox{}\protect\newline 0.3402 (0.2193 to 0.5277) \mbox{}\protect\newline 0.1098 (0.01285 to0.9377) \mbox{}\protect\newline 0.6281 (0.3852 to 1.024) &
  Ref \mbox{}\protect\newline {\textless}0.0001*** \mbox{}\protect\newline 0.0161* \mbox{}\protect\newline 0.0617\\
LDL (mg/dL) &
   &
  \\
Not available \mbox{}\protect\newline Normal \mbox{}\protect\newline Low \mbox{}\protect\newline High  &
  1 \mbox{}\protect\newline 0.3028 (0.1954 to 0.4693) \mbox{}\protect\newline 0.3089 (0.09070 to 1.052) \mbox{}\protect\newline 0.9886 (0.5939 to 1.646) &
  Ref \mbox{}\protect\newline {\textless}0.0001*** \mbox{}\protect\newline 0.0496* \mbox{}\protect\newline 0.9649\\
Urea (mg/dL) &
   &
  \\
 Not available  \mbox{}\protect\newline  Normal \mbox{}\protect\newline  Low &
  1 \mbox{}\protect\newline 0.1692 (0.09703 to 0.2951) &
  Ref \mbox{}\protect\newline {\textless}0.0001***\\
 High  &
  0.7625 (0.4728 to 1.230) &
  0.2656\\
\multicolumn{2}{p{\dimexpr(.6808\linewidth-2\tabcolsep)}}{Serum creatinine (mg/dL)} &
  \\
Not available \mbox{}\protect\newline  Normal \mbox{}\protect\newline  Low \mbox{}\protect\newline  High  &
  1 \mbox{}\protect\newline 3.689 (1.628 to 8.358) \mbox{}\protect\newline 0.5515 (0.02754 to 11.05) \mbox{}\protect\newline 154.3 (37.92 to 627.7) &
  Ref \mbox{}\protect\newline 0.0009*** \mbox{}\protect\newline 0.3811 \mbox{}\protect\newline {\textless}0.0001***\\
\multicolumn{2}{p{\dimexpr(.6808\linewidth-2\tabcolsep)}}{Duration of T2DM (Years)} &
  \\
 {\textless}5 \mbox{}\protect\newline  5-10 \mbox{}\protect\newline  {\textgreater}10 &
  1 \mbox{}\protect\newline 2.653 (1.778 to 3.958) \mbox{}\protect\newline 3.606 (2.362 to 5.504) &
  Ref \mbox{}\protect\newline {\textless}0.0001*** \mbox{}\protect\newline {\textless}0.0001***\\
\multicolumn{2}{p{\dimexpr(.6808\linewidth-2\tabcolsep)}}{Following T2DM education} &
  \\
 Yes \mbox{}\protect\newline  No  &
  1 \mbox{}\protect\newline 1.567 (1.079 to 2.274) &
  Ref \mbox{}\protect\newline 0.0177*\\
Food habits &
   &
  \\
Vegetarian \mbox{}\protect\newline Mixed &
  1 \mbox{}\protect\newline 1.177 (0.7538 to 1.838) &
  Ref \mbox{}\protect\newline 0.4732\\
Physical activity &
   &
  \\
No physical activity \mbox{}\protect\newline Regular exercise &
  1 \mbox{}\protect\newline 0.5188 (0.3727 to 0.7220) &
  Ref \mbox{}\protect\newline {\textless}0.0001***\\
Habit of smoking &
   &
  \\
No \mbox{}\protect\newline Yes \mbox{}\protect\newline Past smoker &
  1 \mbox{}\protect\newline 1.201 (0.6292 to 2.292) \mbox{}\protect\newline 1.554 (0.7835 to 3.083) &
  Ref \mbox{}\protect\newline 0.5781 \mbox{}\protect\newline 0.2039\\
\multicolumn{2}{p{\dimexpr(.6808\linewidth-2\tabcolsep)}}{The habit of drinking alcohol} &
  \\
No \mbox{}\protect\newline Yes \mbox{}\protect\newline Past alcoholic &
  1 \mbox{}\protect\newline 0.7816 (0.4643 to 1.316) \mbox{}\protect\newline 1.223 (0.4643 to 3.220) &
  Ref \mbox{}\protect\newline 0.3526 \mbox{}\protect\newline 0.6834\\
\multicolumn{2}{p{\dimexpr(.6808\linewidth-2\tabcolsep)}}{The habit of taking junk foods } &
  \\
No \mbox{}\protect\newline Weekly once \mbox{}\protect\newline Weekly twice \mbox{}\protect\newline Weekly thrice and more &
  1 \mbox{}\protect\newline 0.7553 (0.3960 to 1.440) \mbox{}\protect\newline 1.145 (0.5930 to 2.212) \mbox{}\protect\newline 1.202 (0.6614 to 2.185) &
  Ref \mbox{}\protect\newline 0.3931 \mbox{}\protect\newline 0.6860 \mbox{}\protect\newline 0.5455\\
Occasionally &
  1.113 (0.7601 to 1.629) &
  0.5824\\
\multicolumn{2}{p{\dimexpr(.6808\linewidth-2\tabcolsep)}}{The habit of taking fruits /fruit juices } &
  \\
No \mbox{}\protect\newline Weekly once \mbox{}\protect\newline Weekly twice \mbox{}\protect\newline Weekly thrice \& more \mbox{}\protect\newline Occasionally &
  1 \mbox{}\protect\newline 0.6703 (0.3332 to 1.348) \mbox{}\protect\newline 0.6691 (0.3542 to 1.264) \mbox{}\protect\newline 0.4854 (0.3042 to 0.7746) \mbox{}\protect\newline 0.9733 (0.6245 to 1.517) &
  Ref \mbox{}\protect\newline 0.2604 \mbox{}\protect\newline 0.2145 \mbox{}\protect\newline 0.0023** \mbox{}\protect\newline 0.9047\\
\multicolumn{2}{p{\dimexpr(.6808\linewidth-2\tabcolsep)}}{The habit of taking soft drinks } &
  \\
 No \mbox{}\protect\newline  Weekly once \mbox{}\protect\newline  Weekly twice \mbox{}\protect\newline  Weekly thrice \& more \mbox{}\protect\newline  Occasionally &
  1 \mbox{}\protect\newline 1.669 (0.5292 to 5.262) \mbox{}\protect\newline 0.6675 (0.1280 to 3.481) \mbox{}\protect\newline 0.2384 (0.05348 to 1.063) \mbox{}\protect\newline 2.253 (1.531 to 3.315) &
  Ref \mbox{}\protect\newline 0.3773 \mbox{}\protect\newline 0.6291 \mbox{}\protect\newline 0.0417* \mbox{}\protect\newline {\textless}0.0001***\\
\multicolumn{2}{p{\dimexpr(.6808\linewidth-2\tabcolsep)}}{The habit of taking tea/coffee } &
  \\
 No &
  1 &
  Ref\\
Daily once without sugar &
  1.124 (0.6001 to 2.105) &
  0.7151\\
Daily twice without sugar &
  1.845 (1.094 to 3.112) &
  0.0208*\\
Daily thrice without sugar &
  1.144 (0.6186 to 2.117) &
  0.6671\\
Daily once with sugar &
  1.214 (0.5607 to 2.627) &
  0.6226\\
 Daily twice with sugar &
  1.230 (0.6214 to 2.435) &
  0.5518\\
Daily thrice with sugar &
  0.9483 (0.3923 to 2.292) &
  0.9061\\
\multicolumn{2}{p{\dimexpr(.6808\linewidth-2\tabcolsep)}}{Situations at working places} &
  \\
 No stress \mbox{}\protect\newline  Stress &
  1 \mbox{}\protect\newline 1.017 (0.7373 to 1.402) &
  Ref \mbox{}\protect\newline 0.9188\\
\tblbottomrule 
\end{longtable}
\endgroup
\end{ThreePartTable}

\makeatletter\@ifundefined{TwoColDocument}{}{\twocolumn}\makeatother 

\begin{table*}[!htbp]
\caption{\boldmath {Medication given for the patients with diabetic retinopathy} }
\label{tw-9b38d0ea9d4b}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.14490000000000002\linewidth-2\tabcolsep}p{\dimexpr.5635\linewidth-2\tabcolsep}p{\dimexpr.2916\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}S. No & Generic Name of Drugs & N (\%)\\
\tblmidrule 
1 &
  Metformin  &
  72 (47.05)\\
2 &
  Glimepiride + Metformin &
  47 (30.71)\\
3 &
  Insulin Isophane + Regular Insulin &
  45 (29.41)\\
4 &
  Teneligliptin  &
  16 (10.45)\\
5 &
  Insulin Regular &
  15 (9.80)\\
6 &
  Glimepiride &
  10 (6.53)\\
7 &
  Pioglitazone  &
  10 (6.53)\\
8 &
  Gliclazide + Metformin  &
  8 (5.22)\\
9 &
  Insulin Glargine &
  7 (4.57)\\
10 &
  Gliclazide &
  6 (3.92)\\
11 &
  Sitagliptin + Metformin  &
  4 (2.61)\\
12 &
  Teneligliptin + Metformin  &
  4 (2.61)\\
13 &
  Metformin + Voglibose &
  4 (2.61)\\
14 &
  Insulin Aspart &
  4 (2.61)\\
15 &
  Glipizide + Metformin &
  3 (1.96)\\
16 &
  Glibenclamide + Metformin &
  3 (1.96)\\
17 &
  Metformin + Vildagliptin &
  3 (1.96)\\
18 &
  Lantus Insulin  &
  2 (1.30)\\
19 &
  Glimepiride + Metformin + Voglibose &
  2 (1.30)\\
20 &
  Glimepiride + Metformin + Pioglitazone  &
  2 (1.30)\\
21 &
  Sitagliptin &
  2 (1.30)\\
22 &
  Acarbose &
  1 (0.65)\\
23 &
  Linagliptin &
  1 (0.65)\\
24 &
  Voglibose &
  1 (0.65)\\
25 &
  Dapagliflozin &
  1 (0.65)\\
26 &
  Empagliflozin &
  1 (0.65)\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}
Therefore, further studies are needed to evaluate the exact impact of urban residence on risk for diabetic retinopathy.

\textbf{Monthly income}

The present study's results revealed that monthly income (P{\textless}0.0001) was significantly associated and was the major risk factor for diabetic retinopathy (OR, 0.1841; 95\% CI, 0.1082 - 0.3133). Therefore, further studies are needed to evaluate the exact impact of monthly income on risk for diabetic retinopathy.

\textbf{Comorbidities }

Hypertension (P \textless\ 0.0001) was positively associated with diabetic retinopathy. \unskip~\citep{767499:18253333} conducted a study to examine the global prevalence and major risk factors for diabetic retinopathy (DR) and gave a conclusion that DR has the potential to be the leading cause of visual impairment and blindness worldwide and also concluded that poorer glycemic and blood pressure control are strongly associated with DR \unskip~\citep{767499:18253333}.  Another study conducted by \unskip~\citep{767499:18253339} also concluded that hypertension was the most significant risk factor. The present study's results are also supported that hypertension (30.1\%, P \textless\ 0.0001) was a risk factor for diabetic retinopathy  (OR, 2.642; 95\% CI, 1.868-3.736). 

\textbf{Physical inactivity }

The present study's results revealed that physical inactivity (63.3\%, P {\textless}0.0001) was significantly associated and was the major risk factor for diabetic retinopathy. Therefore, further studies are needed to evaluate the exact impact of physical inactivity on risk for diabetic retinopathy.

\textbf{Junk foods}

The present study's results revealed that habit of taking junk foods weakly once (19.9\%, P {\textless}0.0001), weakly twice (13.2 \%, P{\textless}0.0001) was significantly associated and was the major risk factor for diabetic retinopathy (weekly once OR, 3.287; 95\%CI, 2.049 {\textendash} 5.274 and weekly twice OR, 2.935; 95\%CI, 1.709 {\textendash}5.038). Therefore, further studies are needed to evaluate the exact impact of the habit of taking junk foods on risk for diabetic retinopathy.

\textbf{Soft drinks}

The present study's results revealed that the habit of taking soft drinks occasionally (24.9\%, P = 0.0073) was significantly associated and was the major risk factor for diabetic retinopathy (OR, 1.642;95\%CI, 1.141-2.364). Therefore, further studies are needed to evaluate the exact impact of the habit of taking soft drinks on risk for diabetic retinopathy.

\textbf{The habit of taking tea/coffee }

The present study's results revealed that the habit of taking tea/coffee twice without sugar (38.1\%, P=0.0465) was significantly associated and was the major risk factor for diabetic retinopathy (OR, 1.598; 95\%CI, 1.006-2.539). Therefore, further studies are needed to evaluate the exact impact of the habit of taking tea/coffee on risk for diabetic retinopathy. 

\textbf{HbA1c}

Poor glycemic control was significantly associated with the development of diabetic retinopathy. Joanne et al., conducted a study to examine the global prevalence and major risk factors for diabetic retinopathy (DR) and gave a conclusion that DR has the potential to be the leading cause of visual impairment and blindness worldwide and also concluded that poorer glycemic and blood pressure control are strongly associated with DR [15]. In the present study, it was significant that poor glycemic control (7-9\% (39.3\%, P=0.0018, {\textgreater}9\% (31.9\%, P{\textless}0.0001) was a risk factor for development of diabetic retinopathy (7-9\% (OR, 1.774; 95\%CI, 1.235-2.547) and{\textgreater} 9\% (OR, 2.275; 95\% CI, 1.529-3.386)). Other relevant studies were conducted by Donghyun et al. and Khalid et al. concluded that poor glycemic control was significantly associated with the development of diabetic retinopathy \unskip~\citep{767499:18253339,767499:18253330}.

\textbf{Serum creatinine}

The present study's results revealed that high serum creatinine levels (14.8\%, P {\textless}0.0001) was significantly associated and was the major risk factor for diabetic retinopathy (OR, 11.55; 95\%CI, 3.415-39.10). Therefore, further studies are needed to evaluate the exact impact of serum creatinine on risk for diabetic retinopathy.

\textbf{Duration of T2DM}

Joanne et al., 2015  conducted a study to examine the global prevalence and major risk factors for diabetic retinopathy (DR) and gave a conclusion that DR has the potential to be the leading cause of visual impairment and blindness worldwide and also concluded that longer diabetes duration was the significant risk factor. In the present study, it was significant that long-standing diabetes (5-10 years (37.8\%, P{\textless}0.0001 and with duration {\textgreater}10 years (37.3\%, P {\textless}0.0001)) was a risk factor for development of diabetic retinopathy (5-10 years (OR, 2.357; 95\%CI, 1.659-3.348) and with duration {\textgreater}10 years (OR, 3.395; 95\%CI, 2.336-4.933). Other relevant studies were conducted by Donghyun et al., Sadiq et al., Khalid et al., Rajiv et al., they also concluded that long-standing diabetes was significantly associated with the development of diabetic retinopathy \unskip~\citep{767499:18253341,767499:18253337}.

\textbf{Drug utilization pattern}

Sekhar et al. conducted a prospective observational study, including 181 patients for 6 months in Bankura Sammilani Medical College and gave a conclusion that metformin was the commonest drug used; glimepiride and metformin combination was the commonest combination therapy\unskip~\citep{767499:18253338}. Our present study's results revealed that Metformin, a combination of Insulin Isophane and Insulin Regular, a combination of Glimepiride and Metformin, Glimepiride, a combination of Metformin and Vildagliptin were most commonly prescribed anti-diabetic drugs to the T2DM patients with retinopathy. \textbf{\space }
    
\section{Conclusion }
Subjects who are married, uneducated patients, nature of work (housewives), rural residents, no income group and risk factors were comorbidities(other diseases, HTN, endocrine diseases, history of CVDs), no physical activity, habit of taking junk foods (weakly once, weakly twice), soft drinks (occasionally), tea/coffee(daily twice without sugar), HbA1c(7-9\%, {\textgreater}9\%), high serum creatinine, duration of diabetes (5-10 years, {\textgreater} 10 years) were significant risk factors for development of retinopathy. Metformin, a combination of Insulin Isophane and Insulin Regular, a combination of Glimepiride and Metformin, Glimepiride, a combination of Metformin and Vildagliptin were most commonly prescribed anti-diabetic drugs to the T2DM patients with retinopathy. 

\textbf{Key findings}
  
  \begin{enumerate}
  \item \relax The prevalence of diabetic retinopathy was found to be 31.28\%.
  \item \relax Retinopathy prevalence was higher in females compared to males (P=0.2608).
  \item \relax The prevalence of retinopathy was significantly higher in the subjects who are married (98.2\%, P=0.0371) compared to unmarried.
  \item \relax The prevalence of retinopathy was significantly higher in the subjects who are poorly educated (69.9\%, P{\textless}0.0001) when compared to educated.
  \item \relax The prevalence of retinopathy was significantly higher in the subjects who are not doing any work when compared to others.
  \item \relax The major comorbidities for the development of retinopathy complications include hypertension (P{\textless}0.0001), history of cardiovascular diseases (P{\textless}0.0001), endocrine diseases (P=0.0223) and other diseases (P{\textless}0.0001).
  \item \relax Locality, physical inactivity, socioeconomic status, food habits, soft drinks, junk foods, the habit of taking tea/coffee are significantly associated with the development of retinopathy complications.
  \item \relax Poor glycemic control, serum creatinine levels are significantly associated with the development of retinopathy complications.
  \item \relax Duration of diabetes ({\textgreater}10years, 37.3\% P{\textless}0.0001, 5-10 years 37.8\% P{\textless}0.0001) was significantly associated with the development of retinopathy complications.
  \item \relax  Metformin, a combination of Insulin Isophane and Insulin Regular, a combination of Glimepiride and Metformin, Glimepiride, a combination of Metformin and Vildagliptin were most commonly prescribed anti-diabetic drugs to the T2DM patients with retinopathy.
  \end{enumerate}
  
    

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