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Type 2 Diabetes and Prediabetes: Self- Care Prevention and Management in Rural Indian Population

Dr. Mrinmayee R. Sonawane,1 Dr. Akhil Ramesh Patil,2* Dr Niraj Suresh More3

1MBBS,MD [General Medicine], Assistant professor, Department of General Medicine, SMBT Institute of Medical Sciences And Research Center, Nasik, Maharashtra, India.

Email id: [email protected]

2*MBBS MD [General Medicine], Associate professor, Department of General Medicine, SMBT Institute of Medical Sciences And Research Center, Nasik, Maharashtra, India.

Email: [email protected]

3MBBS MD [General Medicine], Assistant professor, Department of General Medicine, SMBT Institute of Medical Sciences And Research Center, Nasik, Maharashtra, India.

Email id: [email protected] Corresponding author:

Dr. Akhil Ramesh Patil

Department of General Medicine, SMBT Institute of Medical Sciences And Research Center, Nasik, Maharashtra, India. Email: [email protected]

ABSTRACT:

Background:Various diabetic complications affecting multiple organs in humans remain one of the most common reasons for worry among the medical fraternity, making intervention necessary.

Aims: the present clinical trial was carried out to evaluate the prediabetes and diabetes prevalence and to assess the effect of non-drug diabetic self-management for improving the diabetic status and decreasing the risk factors of diabetes. To increase awareness for diabetes, a population-based approach was developed and used along with individualized lifestyle modifications on self-care and risks in Type 2 diabetics.

Materials and Methods: The study was conducted on 764 rural subjects determined the prevalence of prediabetes and diabetes from the collected data along with differences after intervention in diabetes type 2, normoglycemic, and subjects with deranged fasting glucose levels compared to baseline data. The statistical analysis of collected data was applied for result formulation.

Results:Before intervention and after intervention values for fasting glucose in diabetics were 238.7±12.6and 180.5±81.7respectively, with the p-value of ˂0.0001. Concerning BMI no change was seen with the p-value of 1.000. The caloric intake also improved with a p- value of 0.9428. Similar results were seen for systolic and diastolic blood pressure values.

The waist-hip ratio showed a significant reduction post-intervention with the change in value to 0.90±0.08from 0.87±0.09 with a p-value of 0.1851. The diabetic knowledge value also improved considerably from 3.6±2.5 to 4.55±2.2 with a p-value of 0.1301

Conclusion:The present study concludes that the interventional program, physical activity, and diet counseling can help in effective controlling of the diabetic glucose levels and risk factors associated with diabetes. Hence, such a program can be implemented at a higher level especially in rural India to avoid risk and complications in diabetics. The

Keywords:Diabetes, Prediabetics, deranged fasting glucose, BMI, physical activity, nutrition counseling

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Keynote:Type 2 diabetes is a chronic disease with the continued increase in its prevalence, less accessibility to health care, and lack of awareness on diabetic complications additively pose a high burden on the Indian health-care sector and economy. One effective and economic strategy for managing and preventing type 2 diabetes is lifestyle modifications with diet interventions.

INTRODUCTION

India is heading towards being the Diabetes capital of the World with the increase in cases of adults as well as childhood diabetes causing high morbidity and mortality owing to its multi- organ complications. India has a huge population, with approximately 47 living with undiagnosed Diabetes.1 Approximately 37 million Indians have prediabetes and approximately 73 million with diagnosed diabetes. A huge spike in diabetes cases in India has been seen since the early 1900s owing to an increase in a sedentary lifestyle, obesity, overweight, transitions in nutrition, epidemiology, and economy. Various diabetic complications affecting multiple organs in humans remain one of the most common reasons for worry among the medical fraternity, making intervention necessary.2 This intervention for preventing, managing, and diagnosing diabetes as well as managing complications imparts a high burden on the economy especially on the poor Indian population. The goal for Indian health-care sectors by 2025 is to make diabetes diagnostics and drugs to approximately 80 of the population.3

Patients with Diabetes need to learn about self-care and management of diabetes to prevent long-term complications and have maintained optimum health, failure to which can lead to the development of life-threatening macrovascular and microvascular multi-organ complications. Subjects with diabetes and prediabetes need to learn and maintain these self- care and management strategies to achieve daily normal diabetes status.4 Various such strategies include lifestyle modification including giving up the sedentary lifestyle habits with more physical activity and diet modifications, care to prevent diabetic foot, adequate intake of the prescribed drug at the correct time, regular monitoring of glucose levels, and quitting of adverse habits like alcohol and smoking.5

With an increased understanding of diabetes and prediabetes, there is a focus on individual patient care with an aim to the prevention of diabetes and its complications. Primary diabetic care aims at making diabetic acre accessible to all population and referral to a specialist when needed. As per WHO primary diabetic care should is focused on providing individualized care from qualified health-care providers. Providing this primary care seem very challenging to the Indian health-care system, hence needs to be worked upon and more share of the economy to be spent on this aspect, which can be challenging in developing low-income country.6

The highest prevalence of diabetes is seen in the Indian population in the whole world. It is predicted that by 2030 there will be approximately 75 million diabetics with manifestations at a young age.A huge lot of the Indian population resides in the rural area making approximately 70%. The population residing in the rural areas has low resource medical settings and less availability to modern medical practice.7 Also, as type 2 diabetes is a chronic disease with the continued increase in its prevalence, less accessibility to health care and lack of awareness on diabetic complications additively pose a high burden on the Indian health- care sector and economy. One effective and economic strategy for managing and preventing type 2 diabetes is lifestyle modifications with diet interventions. However, data regarding this intervention is scarce in the modern literature with only a few studies mentioning the positive impact of diet and lifestyle modification on improving diabetic status.8 Hence, the present clinical trial was carried out to evaluate the prediabetes and diabetes prevalence and to assess the effect of non-drug diabetic self-management for improving the diabetic status and

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decreasing the risk factors of diabetes. To increase awareness for diabetes, a population-based approach was developed and used along with individualized lifestyle modifications on self- care and risks in Type 2 diabetics.

MATERIALS AND METHODS

The present study was based on a population-based approach which was carried out at Smt.

MathurabaiBhausahebThorat Institute of Medical Sciences And Research Center [SMBT IMSRC], Nasik, Maharashtra, India; from December 2020 to April 2021. The study adopted on764 subjects of rural population.An attempt was done to involve the influential, public figure, and leaders by initial analysis in the village to explain the design of the study and motivate the subjects to participate in the study and keep trust in the protocol. Intervention and collection of data were done by individuals of expertise in the field. More than 40% of the village population had educational classification less than primary school and hence the oral interview method was considered most appropriate regarding data collection. The informed consent was collected from all study subjects and ethical clearance was taken from the Institutional Ethical committee.

Initially for the survey, all 764 individuals were interviewed where 102 individuals were less than 18 years (10-17) of age, and the remaining 662 were adults. A total of 604 individuals making 79% who completed the survey remaining 21% either denied the survey or migrated to other villages. The interviews and surveys were done by going home to home visits. The data were collected at two time periods including at the time of recruitment of study subjects which is considered baseline and after the intervention. The data collections were carried out by a person qualified to do so.

The data collected included the demographic parameters in the study subject. Capillary blood was used to determine the blood glucose level due to fear of venous blood withdrawal among the majority of study subjects owing to no pre-exposure and fear of the needle. Capillary blood determined the status of prediabetes and diabetes. The same glucometer was used to check the blood glucose levels (fasting). The subjects with not normal blood glucose levels were rechecked. American Diabetes association care standards were used to distinguish between the subjects with normal glucose levels (normoglycemic), subjects with impaired fasting glucose levels, and diabetics. Blood pressure was recorded for each subject using a sphygmomanometer after 10 minutes of rest in the left arm. Two readings were recorded and a third was taken if two had a difference of more than 4mm of mercury. Height and weight measurements were also taken along with hip and thigh circumference recordings. Die counseling was given after assessing the subject knowledge about food using a questionnaire and continuous diet intake assessment was also carried out. Obesity measures were taken based on waist to hip ratio.

Following measures were instilled in the study subjects: diet modification with more fibers and less fat and intake in portions along with the increase in physical activity. Personalized counseling was given to all individuals based on socioeconomic status, age, and sex. Detailed information was provided regarding diabetes and related complications with a focus on its prevention by lifestyle modification, reducing body fat, waist, and weight, diet modification, and stress reduction protocols. Individuals with only deranged fasting glucose levels were counseled separately.Weight reduction protocols were instilled only in overweight individuals. Diet counseling was personalized based on socioeconomic status. Intake of processed food and food rich in sugar was discouraged. Also, the subjects were informed about the importance of regulating and checking blood sugar levels.

The training was provided to the subjects by the persons qualified and trained to do so. The training was given for 3 months including detailed knowledge about prediabetes, diabetes,

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diet counseling, nutrition counseling, associated risk factors, and physical exercises. They were also trained about solving any query and question of the subjects related to diabetes.

The study determined the prevalence of prediabetes and diabetes from the collected data along with differences after intervention in diabetes type 2, normoglycemic, and subjects with deranged fasting glucose levels compared to baseline data. The statistical analysis of collected data was applied for result formulation.

RESULTS

The present clinical trial was carried out to evaluate the prediabetes and diabetes prevalence and to assess the effect of non-drug diabetic self-management for improving the diabetic status and decreasing the risk factors of diabetes. To increase awareness for diabetes, a population-based approach was developed and used along with individualized lifestyle modifications on self-care and risks in Type 2 diabetics.

The study included both males and females. Initially for the survey, all 764 individuals were interviewed where 102 individuals were less than 18 years (10-17) of age, and the remaining 662 were adults. A total of 604 individuals making 79% who completed the survey remaining 21% either denied the survey or migrated to other villages. The interviews and surveys were done by going home to home visits. The data were collected at two time periods including at the time of recruitment of study subjects which is considered baseline and after the intervention. The data collections were carried out by a person qualified to do so. The demographic characteristics of the study subjects are listed in table 1.

The study also assessed the alteration in various factors after intervention and counseling in the adult and youth study subjects with deranged fasting glucose and confirmed diabetics.

These results are described in Table 2.

In minor subjects of less than 18 years of age, 22 subjects had deranged fasting glucose levels and no diabetic subjects as there. Before intervention and after intervention values for fasting glucose were 106.12±6.2 and 88.8±7.8 respectively, this difference shows a statistically significant reduction in the fasting glucose levels in subjects post-intervention with the p- value of ˂0.0001. The values for waist circumference and hip circumference before intervention were 24.5±3.4 and 29.5±4.2, whereas, post-intervention these values were decreased to 23.1±3.2 and 28.6±4.8 with the respective p-values of 0.1670 and 0.5117.

Concerning BMI an increase post-intervention was seen with the value of 17.7±2.2 which was 16.0±1.7 before intervention with the p-value of 0.0064. The caloric intake also improved with a p-value of 0.9816. Similar results were seen for systolic and diastolic blood pressure values. The waist-hip ratio showed a significant reduction post-intervention with the change in value to 0.80±0.006 from 18.5±0.006 with a p-value of ˂0.0001.

In adult subjects of more than 18 years of age, 68 subjects had deranged fasting glucose levels and 29 diabetic subjects. Before intervention and after intervention values for fasting glucose in diabetics were 238.7±12.6and 180.5±81.7respectively, this difference shows a statistically significant reduction in the fasting glucose levels in subjects post-intervention with the p-value of ˂0.0001. The values for waist circumference and hip circumference before intervention were 33.5±4.1and 37.3±3.8, whereas, post-intervention these values were decreased to 31.4±4.6 and 36.1±5.1 with the respective p-values of 0.0718 and 0.3140.

Concerning BMI no change was seen with the p-value of 1.000. The caloric intake also improved with a p-value of 0.9428. Similar results were seen for systolic and diastolic blood pressure values. The waist-hip ratio showed a significant reduction post-intervention with the change in value to 0.90±0.08from 0.87±0.09 with a p-value of 0.1851. The diabetic knowledge value also improved considerably from 3.6±2.5 to 4.55±2.2 with a p-value of 0.1301 (Table 2).

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The study also evaluated the mentioned variables among minors and adults on basis of their glycaemic values distinguishing them to normoglycemic, deranged fasting glucose, and diabetics, and the results are summarized in Table 3. The statistically significant difference in all the variables was seen on comparing the mentioned parameters in normoglycemic, subjects with deranged fasting glucose, and in diabetics.

Demographic parameter Subgroup Number(n=604) Percentage%

Age 10-18 years 86 14.23

18-20 years 147 24.33

21-60 years 248 41.05

More than 60 years

123 20.36

Sex Males 386 63.90

Females 218 36.09

Education Uneducated 179 29.63

Primary school 206 34.10

High school 131 2.68

Graduation or above

88 14.56

Blood Glucose levels Fasting 98.6±7.82 - Postprandial 129.42±9.28 -

Weight (in kg) Underweight 98 16.22

BMI Normal 296 49

Overweight 136 23.01

Obese 74 12.25

Blood pressure (in mmHg)

Systolic B.P 125±7.8 -

Diastolic B.P 89±8.2 -

Smoking 289 47.84

Alcohol Consumption 210 34.76

Physical Activity No activity 436 72.18

Moderate 124 20.52

Heavy 44 7.28

Socioeconomic status Low 289 47.84

Moderate 248 41.05

High 67 11.09

Table 1: Demographic Characteristics of the study subjects

Parameter Before Intervention Post- Intervention p-value Deranged

fasting glucose

Diabetics Deranged fasting glucose

Diabetics Deranged fasting glucose

Diabetics

Young

Individuals (10- 17 years) (n=86)

22 0 22 0 22 0

Fasting Blood 106.12±6. - 88.8±7.8 - ˂0.0001 -

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Glucose Levels 2

BMI 16.0±1.7 - 17.7±2.2 - 0.0064 -

Hip

Circumference

29.5±4.2 - 28.6±4.8 - 0.5117 -

Waist

Circumference

24.5±3.4 - 23.1±3.2 - 0.1670 -

Hip waist ratio 18.5±0.00 6

- 0.80±0.00

6

- ˂0.0001 -

Total Calorie Intake

1618.8±62 4.2

- 1621.9±54

8.9

- 0.9816 -

Systolic B.P 108.6±12.

6

- 101.8±8.4 - 0.0412 -

Diastolic B.P 77.6±8.4 - 72.7±7.5 - 0.0490 - Diabetes

Knowledge Value (Score)

5.2±1.6 - 6.4±1.8 - 0.0243 -

Adults >18 years (n=518)

68 29 68 29 68 29

Fasting Blood Glucose Levels

108.4±8.2 238.7±12.

6

96.5±15.5 180.5±81.

7

˂0.0001 0.0004

BMI 23.3±4.3 23.3±3.4 23.5±4.6 23.3±4.4 0.7938 1.0000

Hip

Circumference

36.6±3.8 37.3±3.8 35.5±3.5 36.1±5.1 0.0814 0.3140 Waist

Circumference

33.3±4.4 33.5±4.1 31.1±4.7 31.4±4.6 0.0056 0.0718 Hip waistRatio 0.90±0.06 0.90±0.08 0.87±0.07 0.87±0.09 0.0082 0.1851 Total Calorie

Intake

1556.5±57 4.6

1464.4±49 8.8

1842.2±53 6.1

1473.3±43 9.7

0.0032 0.9428 Systolic B.P 129.8±15.

4

132.9±18.

6

123.3±12.

5

129.5±19 0.0281 0.4939 Diastolic B.P 93.2±14.7 92.5±18.4 82.4±13.5 87.1±15.6 ˂0.0001 0.2331 Diabetes

Knowledge Value (Score)

3.3±2.6 3.6±2.5 4.5±2.3 4.55±2.2 0.0051 0.1301

Table 2: Alteration in various Diabetic factors post-intervention

Parameter Normoglycemics Deranged

fasting glucose

Diabetics (n=0)

p-value

Young Individuals (10-17 years) (n=86)

64 22 0

BMI 16.55±2.47 17.7±2.2 - 0.0564

Hip Circumference 28.13±2.82 28.6±4.8 - 0.5801

Waist Circumference 22.9±2.33 23.1±3.2 - 0.7541

Hip waistRatio 0.81±0.04 0.80±0.006 - 0.3798

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Total Calorie Intake 1406.78±546.08 1621.9±548.9 - 0.1152

Systolic B.P 106.33±11.02 101.8±8.4 - 0.0824

Diastolic B.P 69.64±8.86 72.7±7.5 - 0.1508

Diabetes Knowledge Value (Score)

4.41±1.98 6.4±1.8 - 0.0001

Adults >18 years (n=518) 421 68 29

BMI 20.24±3.59 23.5±4.6 23.3±4.4 0.065

Hip Circumference 32.60±3.06 35.5±3.5 36.1±5.1 ˂0.0001 Waist Circumference 27.27±4.02 31.1±4.7 31.4±4.6 0.037 Hip waistRatio 0.85±0.05 0.87±0.07 0.87±0.09 0.09 Total Calorie Intake 1649.7±583.3 1842.2±536.1 1473.3±43

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0.005 Systolic B.P 117.05±18.37 123.3±12.5 129.5±19 0.206 Diastolic B.P 78.8±13.78 82.4±13.5 87.1±15.6 0.059 Diabetes Knowledge Value

(Score)

3.76±2.42 4.5±2.3 4.55±2.2 0.008

Table 3: Comparison of normoglycemic, deranged fasting glucose, and diabetics among minors and adult study subjects

DISCUSSION

The study included both males and females. Initially for the survey, all 764 individuals were interviewed where 102 individuals were less than 18 years (10-17) of age, and the remaining 662 were adults. A total of 604 individuals making 79% who completed the survey remaining 21% either denied the survey or migrated to other villages. The interviews and surveys were done by going home to home visits. The data were collected at two time periods including at the time of recruitment of study subjects which is considered baseline and after the intervention. The data collections were carried out by a person qualified to do so. It was seen that the mean fasting glucose level in the study population was 98.6±7.82 and the postprandial value was129.42±9.28. Regarding weight 98 (16.22%) subjects were underweight, 296 (49%) had normal weight, 136 (23.01%) were overweight, and 74 (12.25%) were obese. 72.18%(n=436) had a sedentary lifestyle, 124 (20.52%) did moderate physical activity, and 44 (7.28%) did heavy activity. Concerning socio-economic status 47.84% (n=289) subjects had low socioeconomic status, 41.05% (n=248) had medium, and 11.09% (n=67) had low socioeconomic status. These results were in agreement with the studies by Ramachandran A et al9 in 2004 and Ramachandran A et al10 in 2006 where the authors reported similar results in terms of literacy, socioeconomic status, and physical activity.

In minor subjects of less than 18 years of age, 22 subjects had deranged fasting glucose levels and no diabetic subjects as there. Before intervention and after intervention values for fasting glucose were 106.12±6.2 and 88.8±7.8 respectively, this difference shows a statistically significant reduction in the fasting glucose levels in subjects post-intervention with the p- value of ˂0.0001. The values for waist circumference and hip circumference before intervention were 24.5±3.4 and 29.5±4.2, whereas, post-intervention these values were

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decreased to 23.1±3.2 and 28.6±4.8 with the respective p-values of 0.1670 and 0.5117.

Concerning BMI an increase post-intervention was seen with the value of 17.7±2.2 which was 16.0±1.7 before intervention with the p-value of 0.0064. The caloric intake also improved with a p-value of 0.9816. Similar results were seen for systolic and diastolic blood pressure values. The waist-hip ratio showed a significant reduction post-intervention with the change in value to 0.80±0.006 from 18.5±0.006 with a p-value of ˂0.0001. Similar findings were suggested by Pinhas-Hamiel Oet al11 wherein adolescents with type 2 diabetes comparable results were seen and SnijderMB et al12 in 2003where similar waist-hip ratio and circumference was seen.

In adult subjects of more than 18 years of age, 68 subjects had deranged fasting glucose levels and 29 diabetic subjects. Before intervention and after intervention values for fasting glucose in diabetics were 238.7±12.6and 180.5±81.7respectively, this difference shows a statistically significant reduction in the fasting glucose levels in subjects post-intervention with the p-value of ˂0.0001. The values for waist circumference and hip circumference before intervention were 33.5±4.1and 37.3±3.8, whereas, post-intervention these values were decreased to 31.4±4.6 and 36.1±5.1 with the respective p-values of 0.0718 and 0.3140.

Concerning BMI no change was seen with the p-value of 1.000. The caloric intake also improved with a p-value of 0.9428. Similar results were seen for systolic and diastolic blood pressure values. The waist-hip ratio showed a significant reduction post-intervention with the change in value to 0.90±0.08from 0.87±0.09 with a p-value of 0.1851. The diabetic knowledge value also improved considerably from 3.6±2.5 to 4.55±2.2 with a p-value of 0.1301. These findings were in agreement with the studies by JoshiPet al13 in 2007 and Chow CK et al14 in 2008 wherein adult subjects with type 2 diabetes similar results in terms of BMI, caloric intake, and glucose levels were seen.

CONCLUSION

The present study concludes that the interventional program, physical activity, and diet counseling can help in effective controlling of the diabetic glucose levels and risk factors associated with diabetes. Hence, such a program can be implemented at a higher level especially in rural India to avoid risk and complications in diabetics. The study focuses on applying for such programs at social levels as intervention, to attain desirable results in subjects with deranged fasting glucose levels and in diabetics. However, more such longitudinal studies with larger sample size, longer monitoring period, and different geographical areas are required to reach a definitive conclusion.

REFERENCE

1. World Health Organization. Global report on diabetes. Geneva, Switzerland; 2016.

2. AN Zeba, HF Delisle, G Renier. Dietary patterns and physical inactivity, two contributing factors to the double burden of malnutrition among adults in Burkina Faso, West Africa J Nutr Sci. 2014; 3:50.

3. M.J. Gowda, U. Bhojani, N. Devadasan, T.S. Beerenahally. The rising burden of chronic conditions among urban poor: a three-year follow-up survey in Bengaluru, India. BMC Health Serv Res 2015;15: 330.

4. A. Chawla, R. Chawla, S. Jaggi. Microvascular and macrovascular complications in diabetes mellitus: distinct or continuum? Indian J. Endocrinol. Metab. 2016;20:546-55 5. SamiW,Ansari T, ButtNS, HamidMRA.Effect of diet on type2 diabetes mellitus: a

review.IntJHealthSci(Qassim).2017;11:65–71.

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7. Nirmala PV, Gudivada M, Lashmi C. Comparative study of the prevalence of type-2 diabetes mellitus in various demographic regions of Andhra Pradesh, India: a population- based study. Int J MCH AIDS 2016;5:103–11.

8. RM Anjana, H Ranjani, R Unnikrishnan, MB Weber, V Mohan, KM Narayan. Exercise patterns and behavior in Asian Indians: data from the baseline survey of the Diabetes Community Lifestyle Improvement Program (D-CLIP). Diabetes Res Clin Pract, 2015;107:77-84.

9. Ramachandran A, Snehalatha C, Baskar AD, Mary S, Kumar CK, Selvam S, Catherine S, Vijay V: Temporal changes in the prevalence of diabetes and impaired glucose tolerance associated with lifestyle transition occurring in the rural population in India.

Diabetologia. 2004;47:860–5.

10. Ramachandran A, Snehalatha C, Mary S, Mukesh B, Bhaskar AD, Vijay V, Indian Diabetes Prevention Programme (IDPP): The Indian Diabetes Prevention Programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1). Diabetologia. 2006;49:289–7.

11. Pinhas-Hamiel O, Dolan LM, Daniels SR, Standiford D, Khoury PR, Zeitler P: Increased incidence of non-insulin-dependent diabetes mellitus among adolescents. J Pediatr.

1996;128:608–15.

12. SnijderMB,DekkerJM,VisserM,Yudkin JS, Stehouwer CD, Bouter LM, Heine RJ, NijpelsG,SeidellJC:Largerthighandhip circumferences are associated with better glucose tolerance: the Hoorn study. Obes Res 2003;11:104–11.

13. JoshiP,IslamS,PaisP,ReddyS,DorairajP, Kazmi K, Pandey MR, Haque S, Mendis S, RangarajanS, YusufS. Risk factors for early myocardial infarction in South Asians compared with individuals in other countries. JAMA 2007;297:286–94.

14. Chow CK, Naidu S, Raju K, Raju R, Joshi R, Sullivan D, Celermajer DS, Neal BC:

Significant lipid, adiposity and metabolic abnormalities amongst 4535 Indians from a developing region of rural Andhra Pradesh. Atherosclerosis. 2008;196:943–52.

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