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Cross Cultural Studies in India

A POPULATION BASED STUDY OF DIABETES AND METABOLIC CORRELATES OF CARDIOVASCULAR RISK FACTORS AMONG ASIAN INDIANS.

Funded by Centers for Disease Control

This is a multicenter study involving a consortium of 4 North American Institutions and 2 Indian Institutions for a cross-cultural and epidemiological study that examines the risk factors for Type 2 diabetes mellitus (DM) and cardiovascular disease (CVD) in rural Indians, urban Indians, and Indian Americans in the US. The proposed study design is a community-based random study that will involve, in all, 500 rural Indians, 500 urban Indians, and 400 immigrant Asian Indians in the United States. Of the five US institutions, two have specific expertise in clinical endocrinology and diabetes (Joslin Diabetes Center and Brigham and Women’s Hospital), one in epidemiology and public health (Texas A&M University), 2 in atherosclerosis and cardiovascular disease (CADI Research Foundation and University of California San Diego). Of the two institutions selected from India one has extensive expertise in diabetes and metabolic diseases (All India Institute of Medical Sciences, New Delhi) while the other one is well known for nutrition and diabetes education (Gandhigram University, Madurai). These institutions have agreed to, and are equally committed to the overall research project, and to work together to recruit, in all:a) 400 randomly selected Asian Indians in the United States, aged 18 years and older, from 3 sites with 200 participants in Edison NJ, 100 participants in Boston MA, and 100 in San Diego CA. The sited from the US would include Edison NJ, San Diego CA, and Boston MA. b) 1000 Asian Indians in India from 2 sites: New Delhi (500 urban population), and Aalamarathupatti in Dindugal District affiliated with the (500 rural population). All respondents will be assessed for risk factors for CVD and Type 2 diabetes mellitus. Texas A&M University will be the formal Data Coordinating Center (DCC). Atherotech Laboratory in Alabama and Diabetes Diagnostic Laborary in Missouri will provide the core facilities in the US for diagnostic services of plasma lipids, lipoproteins, Homocysteine, C-Reactive proteins, hemoglobin A1c test, and fasting insulin while the All India Institute of Medical Sciences in New Delhi will provide core facilities for similar bioclinical marker studies for the Indian populations. Standardization of blood tests in the US and India will be conducted among five of the study site coordinators and PIs for the cross-cultural comparison. Two of the PIs (Dr. Misra and Dr. Patel) are the principal investigators of the AAPI-DIA study. All six site coordinators will be involved in data analysis and publications according to their areas of research interest. Since this project will build on AAPI-DIA and AAPI-GRI, there will be a significant reduction in the planning/implementation time and overall data collection is expected to be completed within a 12-month period.

Objective: The overall objective of this project is to study the prevalence rate and identify and compare a comprehensive set of social, environmental and biochemical determinants for T2DM and CVD among rural and urban Asian Indians, and migrant Asian Indians in the USA. The proposed cross-cultural and community-based random study will address the following major aims:

1. To assess the prevalence of metabolic derangements related to insulin resistance and T2DM and cardiovascular risk factors in migrant Asian Indians in the USA and native Asian Indians in India according to rural-urban divide and socio-economic strata.

2. To identify a comprehensive set of determinants for T2 DM and CVD among the above populations. The risk factors to be studied include:

a. Demograpghic variables: gender, age, income, and education.

b. Family history: T2DM, premature CVD, stroke, peripheral vascular disease, lipid disorders.

c. Lifestyle factors: physical activity, stress, smoking (chewing tobacco, smoking bidi, hookah (indigenously made tobacoo smoking device) and cigarette), alcohol intake.

d. Dietary profile: total calories, total fat, saturated fat, fibre, and ?-3 polyunsaturated fatty acids.

e. Blood pressure measurement.

f. Anthropometry: Birth weight (as recalled), current weight, waist and hip circumferences, BMI, skinfolds thicknesses at 4 sites (suprailiac, subscapular, biceps and triceps) and total body fat estimated by bioelectrical impedance.

g. Biochemical profile: Fasting blood glucose and serum insulin, glycosylated heamoglobin A1c, lipid profile (total cholesterol, seum triglycerides, and high-density lipoprotein cholesterol[HDL-C]), LDL subclasses, HDL subclasses, adiponectin, plasma homocysteine, lipoprotein(a), and C-reactive protein.

Significance of the Proposed Study

The proposed cross-cultural and community-based epidemiological study using random multicluster sampling design is one of the most powerful designs for quantifying the prevalence rate and for understanding the epidemiology of T2DM and CVD and therefore making it an efficient approach to evaluate our specific goals. This research should contribute significantly towards new information on T2DM and CVD risk factors among Asian Indians. Furthermore, it will also generate baseline data that is lacking at present for the Asian Indian community in USA. Our expectations are that, at the conclusion of this research, we will be able to narrow the focus to a set of specific factors that will be used to develop primary prevention and management strategies for T2DM and CVD to reduce premature morbidity and mortality. Moreover, the results of the present study might influence the policy of National Diabetes and CVD Control Program initiated by the Government of India and health directives for South Asian minority group in USA.

INVESTIGATORS

Ranjita Misra, PhD, CHES, Principal Investigator. Dr. Misra is an Associate Professor, Department of Health and Kinesiology, Texas A&M University, TX. Her research focus is health promotion behaviors and diabetes research and is the PI of an epidemiological study investigating risk factors for diabetes and cardiovascular disease among Indian Americans in US.

Anoop Misra, MD is Professor of Medicine, All India Institute of Medical Sciences, New Delhi. He has been working on the obesity, metabolic syndrome, and T2DM in the Asian Indians. He has extensive experience in conducting epidemiological studies and in-depth metabolic investigations.

T.G.Patel, MD is the program chief, Renal Diseases, Oncology, & Diabetes, Veterans Health Affairs, Washington DC. He has extensive clinical experience on T2DM and is the co-investigator of the epidemiological study for Indian Americans in the US.

Om Ganda, MD is Associate clinical Professor of Medicine, Harvard Medical School, Boston, MA and a physician at the Joslin Clinic, Joslin Diabetes Center, Boston, MA. He has over 90 publications in the area of diabetes research.

Padmini Balagopal, MS B.Ed.RD CDE IBCLC is a clinical Nutritionist and a Registered Dietitian (for 30 years) who has been Board-Certified as a Diabetes Educator. She has worked in the areas of nutrition, health education, and diabetes management. Since 1995, she is a PI of the AAPI-GRI study and has working on nutrition and diabetes counseling projects in schools, villages and in clinics in Tamilnadu, India since 1995

N. Kamalamma, PhD., is Professor of Home Science and an administrator at Gandhigram University and also the PI for the AAPI-GRI project. She will act as a liaison with the 3 villages selected for the rural site, villages affiliated with Gandhigram Univeristy. She has an impressive background and many successful rural programs in health and sanitation. She is familiar with the unmet needs (such as an increase in diabetes) and is committed to reduce the health disparities in that area. She is familiar with the cultural barriers and ways to overcome them, the formal and informal leaders, and the ethos of the villages all of which can lend valuable input to ensure the success of this project.

Dr. Sunder Mudaliar is Assistant Professor, University of California San Diego, an epidemiologist and practicing family practitioner working in the field of decision analysis and the mathematical modeling of health outcomes.

Dr.Purushotham Kotha is a clinical endocrinologist specializing in diabetes and clinical trials. He has conducted clinical trials and also has research studies on Asian Indians in the United States.

Dr. Vibha Bhatnagar is Assistant Professor, University of California San Diego and of a Premed student at Revelle College, University of California San Diego.

Raji Annaswamy, MD is Instructor in Medicine, Harvard Medical School and Associate Physician Brigham & Women's Hospital, Boston MA. Her research focus is to understand the pathophysiology of insulin resistance, and its cardiovascular complications (Vascular Dysfunction and Atherosclerosis) as well as ethnic differences (effects of genetic and environmental influence) in the incidence of diabetes and cardiovascular complications.

Dr. Reema Patel is at University of Pennsylvania and a resident of Edison NJ. She has been actively involved in the Asian Indian community educational and outreach programs in Edison NJ. She has volunteered her services for AAPI-DIA study.