President-India Diabetes Research Foundation
Chairman–Dr.A.Ramachandran’s Diabetes Hospitals
Visiting Professor–Imperial College, UK
Director, Industrialist & Business Adviser
Director, Health Education Dietician
Dr.Samith A Shetty
Senior Consultant Bio-Chemistry
The research studies have focused on epidemiology of diabetes, cardio-metabolic risk factors in adults and children, complications of diabetes, primary prevention of diabetes, biochemical aspects, cost - effective modes of intervention and quality of diabetes care in India. The outcomes of these studies have major relevance assessing the magnitude of the problem of diabetes in India, its clinical and economic burden, deficiencies in achieving the desired goal in control of diabetes and several social cultural hurdles faced in implementing adequate health care.
Series of urban and rural epidemiological studies have resulted in a wealth of knowledge on various aspects, the pathogenesis, risk factors and temporal changes in the prevalence of diabetes, pre-diabetes and cardiovascular risk factors in India.
This extensive work has resulted in large number of publications in reputed international and national journals, also over 30 chapters in various medical textbooks. Prof.A.Ramachandran, Steering Committee Member of International Diabetes Federation (IDF) Task Force on Diabetes and Non Communicable Diseases (NCD) Prevention, Policy and Practice, has been partly responsible for the Government of India - National Programme for Prevention and Control of Diabetes, Cardiovascular risk factors and stroke (NPDCS). IDRF participates in NPDCS programme.
Studies on assessment of public awareness about diabetes and its complications using a validated questionnaire.
We had assessed the awareness about diabetes and its complications, the need for early detection and control of diabetes in more than 50,000 persons. It is noted that awareness is generally poor even among the family members of diabetic patients. Therefore several awareness camps have been conducted using didactic lectures, audio visual programmes etc. in different parts of the city and even among the rural populations. Patient education on self management of diabetes is being conducted on daily basis to the patients attending the clinic – Dr. A.Ramachandran’s Diabetes Hospitals which is the sister concern of the institution. It has been noted that this programme helps to empower the patients for self management of the disease.
Prevention of diabetes
Indian Diabetes Prevention Programmes IDPP 1 and IDPP 2 have been the pioneer studies from South Asia which have shown that moderate, but consistent lifestyle modification is effective in preventing diabetes in high risk subjects. These studies have also highlighted several peculiarities in the Indians with respect to the risk factors and the response to therapeutic interventions. Among Indians a new translation research project is now in progress to identify a cheaper and widespread communication strategy such as SMS by cell phones, to motivate persons with high risk for diabetes to adhere to the LSM strategies.
Biochemical studies in Diabetes
Indians show many peculiar characteristics in the clinical and biochemical features related to diabetes. This will have impact on the management of the disease. Therefore the studies on pathophysiologic mechanism such as the pattern of insulin secretion and insulin action, presence of lipid abnormalities have been studied which have direct clinical implication in the management of diabetic patients. Extensive studies have also been done on the relevance for risk factors of heart diseases among Indian patients with diabetes, both at the population level and in the clinic. These studies helped to make a better risk assessment in the diabetic patients and to initiate appropriate therapy for co morbid conditions.
Data Sharing with international research organisations such as:
- World Health Organisation (WHO)
- International Diabetes Federation (IDF)
- DECODA –Study group, Europe
- DETECT-2-Early Detection of Type 2 Diabetes, Europe
- INTERACT -Study on interaction of genes and lifestyle leading to diabetes,Medical Research Council, Cambridge, UK and European Commission
- National Health Service and Harvard University, US
- Imperial College, London
Research Programmes undertaken during the last 5 years
1. Insulin Resistance and Clustering of Cardiometabolic Risk Factors in Urban Teenagers in Southern India.
Scope: The occurrence of cardiometabolic risk variables, their clustering, and their association with Insulin resistance among 2640 healthy adolescents in urban south India were studied. Cardiometabolic abnormalities were present in nearly 68% of young healthy Asian-Indian adolescents. Insulin resistance is associated with individual cardiometabolic factors, and plasma insulin showed association with clustering of some variables.
2. Plasma Adiponectin Does Not Correlate With Insulin Resistance and Cardiometabolic Variables in Nondiabetic Asian Indian Teenagers
Scope: The objectives of this study were to determine age- and sex-specific concentrations of adiponectin in 196 Asian Indian teenagers and adults and to assess whether its blood levels correlated with insulin resistance and other cardiometabolic parameters. It was found that in Asian Indian adults and teenagers, adiponectin did not correlate directly with measures of insulin sensitivity, overweight and other cardiometabolic variables.
3. Awareness about diabetes and its complications in the general and diabetic population in a city in southern India
Scope:The study was done to find out the levels of awareness on diabetes in urban adult Indian population and to identify factors that influenced the awareness, including presence of diabetes. Knowledge regarding causes of diabetes, its prevention and the methods to improve health was significantly low among the general population. Diabetic subjects had better knowledge about symptoms of diabetes and the preventive aspects. Awareness was low especially in women and subjects with low education. The study highlights the urgent need to spread awareness about diabetes in the general population.
4. High Prevalence of Diabetes and Cardiovascular Risk Factors Associated With Urbanization in India
Scope: Prevalence of diabetes, impaired glucose tolerance (IGT), impaired fasting glucose (IFG), and cardiovascular risk factors between a city (n= 2192), a town (n=2290), and periurban villages (PUVs) (n=2584) in southern India were compared and temporal changes in the city and PUVs were also looked into. Present and previous data in the city and the PUVs were compared. Overweight, elevated waist circumference, hypertension and dyslipidemia were more prevalent in the city. Diabetes increased from 13.9% to 18.6% in 6 years and IGT decreased significantly in the city. The town and city had similar prevalence; in the PUVs diabetes prevalence, had increased compared with that in a previous survey. Cardiometabolic abnormalities were more prevalent in urban populations
5. Beneficial effects of strategies for primary prevention of diabetes on cardiovascular risk factors: results of the Indian Diabetes Prevention Programme
Scope: In subjects with impaired glucose tolerance (IGT) who participated in the Indian Diabetes Prevention Programme (IDPP), abnormalities related to body mass index (BMI), waist circumference (WC), blood pressure (BP), lipid profile and electrocardiography were analysed. The result was Asian Indian IGT subjects were observed to have a high prevalence of cardiovascular risk factors. LSM and MET had beneficial effects on the atherogenic phenotype of lipids but had no influence on blood pressure
6. Changes in Insulin Secretion and Insulin Sensitivity in Relation to the Glycemic Outcomes in Subjects With Impaired Glucose Tolerance in the Indian Diabetes Prevention Programme-1
Scope: The Indian Diabetes Prevention Programme-1 (IDPP-1) showed that lifestyle modification (LSM) and metformin were effective for primary prevention of diabetes in subjects with impaired glucose tolerance (IGT). A 3 year follow-up showed, risk reduction relative to control group was more in LSM and LSM plus MET groups. In this analysis, changes in insulin secretion and action in improving the outcome were studied. In the IDPP-1 subjects, beneficial outcomes occurred because of improved insulin action and sensitivity caused by the intervention strategies
7.Pioglitazone does not enhance the effectiveness of lifestyle modification in preventing conversion of impaired glucose tolerance to diabetes in Asian Indians: results of the Indian Diabetes Prevention Programme-2 (IDPP-2)
Scope: This was a 3 year, prospective, randomized placebo-controlled study in 407 IGT subjects. The objective was to study whether combining pioglitazone with lifestyle modification would enhance the efficacy of lifestyle modification in preventing type 2 diabetes in Asian Indians with impaired glucose tolerance. The results showed that lifestyle modification (improved physical activity and healthy diet practices) reduced the conversion to diabetes, but addition of pioglitazone (30mg/day) to lifestyle modification did not improve the efficacy.
8. Cardiovascular risk factors in the normoglycaemic Asian-Indian population—influence of urbanization
Scope: The aim of this study was to investigate the prevalence of cardiovascular risk factors in normoglycaemic Asian-Indians and its association with urbanization and plasma glucose. The study revealed high prevalence of cardiovascular risk factors even among normoglycaemic individuals, and this is highest in urban areas. Fasting plasma glucose level showed an association with dyslipidaemia but not hypertension
9. Immediate impact of a diabetes training programme for primary care physicians—An endeavour for national capacity building for diabetes management in India
Scope: National capacity for management of diabetes has to be strengthened by improving knowledge of physicians treating diabetes, especially in semi urban and rural areas. A training programme was formulated and conducted at national level, as a step towards this goal. The training significantly improved knowledge on treatment, complications, pathophysiology and diagnosis of diabetes. Patient education and team-training were considered important in diabetes management. Well-planned short training programmes are useful in improving knowledge and in creating enthusiasm to improve diabetes care and awareness.
10. Multifaceted Determinants for Achieving Glycemic Control The International Diabetes Management Practice Study (IDMPS)
Scope: The International Diabetes Mellitus Practice Study is a 5-year survey documenting changes in diabetes treatment practice in developing regions. The analysis of the first phase showed that both in type1 and type 2 diabetes patients, in Latin America, Eastern Europe and Asia including India, Korea, China, Indonesia, Hong Kong, Taiwan, Malaysia, and Thailand, only about one third of the patients achieved the desired goal of glycaemic and lipid control. It was observed that in developing countries, factors pertinent to patients, doctors, and health care systems all impact on glycemic control.
11. Predictive value of HbA1c for incident diabetes among subjects with impaired glucose tolerance—analysis of the Indian Diabetes Prevention Programmes
Scope: The objectives of this study were to assess the predictive value of baseline HbA1c for incident diabetes among the participants with impaired glucose tolerance in the Indian Diabetes Prevention Programmes 1 and 2. Baseline HbA1c values had heterogenous distribution. The distribution was similar in isolated impaired glucose tolerance or in impaired glucose tolerance in combination with impaired fasting glucose. A progressive increase in diabetes occurred with increasing HbA1c. HbA1c showed the strongest association with incident diabetes in the multiple logistic regression analysis (odds ratio 3.548, P < 0.0001).
12. Efficacy of Primary Prevention Interventions When Fasting and
Postglucose Dysglycemia Coexist-Analysis of the Indian Diabetes Prevention Programmes (IDPP-1 and IDPP-2)
Scope: Impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) have different pathophysiological abnormalities, and their combination may influence the effectiveness of the primary prevention tools. The hypothesis was tested in this analysis, which was done in a pooled sample of two Indian Diabetes Prevention Programmes (IDPP-1 and IDPP-2). Subjects with IGT_IFG had a higher proportion developing diabetes in 3 years and a lower rate of reversal to normoglycaemia .The effectiveness of primary prevention strategies appears to be similar in subjects with iIGT or with combined IGT_IFG. However, the possibility remains that a larger study might show that the effectiveness is lower in those with the combined abnormality.
13. Relationship Between A1C and Fasting Plasma Glucose in Dysglycemia or Type 2 Diabetes-An analysis of baseline data from the ORIGIN trial
Scope: Baseline A1C and FPG data from the Outcome Reduction with Initial Glargine Intervention (ORIGIN) trial participants (n=12,527) were analyzed to 1) elucidate the relationship between A1C and FPG in people with moderate dysglycemia (A1C 5.6–9.0% [38–75 mmol/mol]) and additional risk factors for cardiovascular disease, 2) determine whether this relationship is altered by use of an OAD, and 3) study whether geographic and ethnic differences exist. A strong relationship between FPG and the corresponding A1C was seen across different geographic regions and ethnic groups. A smaller increase in A1C per unit increase in FPG occurred for persons taking an OAD versus those not taking an OAD.
14. Reinforcement of Adherence to Prescription Recommendations in Asian Indian Diabetes Patients Using Short Message Service (SMS)-A Pilot Study
Scope: This study was done to investigate the acceptability and feasibility of using short message services (SMS) via cell phones to ensure adherence to management prescriptions by diabetic patients. Type 2 diabetic patients with 5 or more years of diabetes and having HbA1c between 7.0% to 10% were randomized to the control arm (n=105) to receive standard care and to the intervention arm (SMS, n=110). Messages in English on principles of diabetes management were sent once in 3 days. The study duration was 1 year. A comparative assessment of the clinical, biochemical and anthropometric outcomes was made among the groups at the annual visit. SMS was acceptable to the patients and the median number requested was 2 per week. HbA1c and plasma lipids improved significantly in the SMS group. The pilot study showed that frequent communication via SMS was acceptable to diabetic patients and it helped to improve the health outcomes.
On-going Research Programmes
1. The Role of Information Technology in the Prevention of Type 2 Diabetes- Indian Diabetes Prevention Programme-3 (IDPP-3)
Scope: An India-UK collaborative project, under the UKERI initiative; a proposal developed to validate the usefulness of Information Technology for primary prevention of diabetes. To study whether diabetes prevention can be achieved at lower cost using personalized feedback via mobile phones e-mails with information based on body weight, diet and physical activity. The study initiated in August 2009 and will last for 36 months with a target population of 555. Findings from the study will help to plan community based prevention programmes using cheaper mode of communication to educate and motivate large number of people.
2. A pragmatic and scalable strategy using mobile technology to promote sustained lifestyle changes to prevent type 2 diabetes in India and the UK.
Scope: This project initiated in January 2011 funded by the Indian Council of Medical Research (ICMR) and Medical Research Council (MRC) aims to:
(a)To develop and evaluate a pragmatic and scalable approach to identifying people at high risk of developing type 2 diabetes in India.
(b)To develop a scalable lifestyle modification programme and to prepare a quality assured training programme for the delivery of the intervention by community health workers.
(c)To assess the cost-effectiveness of the lifestyle modification programme on the progression to diabetes over 2 year period.
(d)To assess the cost-effectiveness of the lifestyle modification programme on change in objectively measured physical activity levels.
The project is expected to bring a breakthrough in the field of translational research through innovative strategies on primary prevention of diabetes.
3. Development and implementation of Health Communication and behaviour change tools through smart phone based communication programmes for health and hygiene initiatives.
Scope: Unilever Discover, UK (Unilever Corp.) has tied up with our foundation to work on a proposal on Diabetes Care Programme in India. A user friendly interactive smart-phone application has been developed as a toolkit to sensitize and educate the public on diabetes awareness, prevention and improved self management of diabetes. The programme is mainly set to target the corporates and executives who cannot afford time for personal clinic visits or health check-ups. This will also combine medical treatment, and utility of personal healthcare products for complete diabetes management. A preliminary pilot study to test the utility and acceptability of this application is underway.
4. INTERACT: Interaction of genetic and lifestyle factors on the incidence of type 2 diabetes.
Scope: This project mainly aims to study the gene-environmental interaction in the causation of diabetes. The project funded by the European Union involves a global consortium of 29 centres. IDRF the only site from Asia has partnered with MRC - Epidemiological unit, Institute of Metabolic Science in coordinating the study. The project is completed in Dec 2011, the data is being analysed in Cambridge University.
5.DIABSMART: Development of a new generation of DIABetic footwear using an integrated approach and SMART materials.
Scope: This project was recently awarded funding by the European Union under the Maire Curie Seventh Framework Programme. The main objectives include: (1) the design and development of an integrated system of diabetic foot assessment, (2) to validate the newly developed system using experimental methods, (3) to develop a suitable material to meet the mechanical and clinical requirements, and (4) to evaluate the mechanical and clinical effectiveness of material choice in reducing the potential risk of foot complications.
This project is essentially a cross-sector collaboration that combines the industrial expertise of Salts Healthcare Ltd, and Technofootbed SL, Spain scientific and technical expertise of Hochschule Magdeburg, Germany and Staffordshire University along with the clinical expertise from Dr. A. Ramachandran’s Diabetes Hospitals through India Diabetes Research Foundation in an effort to customise the footwear products for diabetes considering the individual patient’s needs and requirements from a clinical perspective.
CLINICAL RESEARCH & CLINICAL TRIALS
IDRF operates as a Site Management Office (SMO) for the conduct of Clinical Trials in Diabetes / Cardio vascular Disease / Hypertension.
Salient Features of the SMO
- Well equipped local lab facility
- Experienced Site Coordinators
- Facility to conduct Phase –II / III / IV Trials
- Secure Drug Storage Area
- Secure Document Storage Area
- Archival Facility
- Electronic Medical Records
- Facility for EDC / IVRS
- High – Speed Internet
Phase – III: 06
Phase –IV: 07
- SIBA - Study on Soluble Insulin Basal Glargine
An open label, global, multicentric study to compare the efficacy and safety of 3 different insulin dosing regimens of Soluble Insulin Basal Glargine / insulin glargine with or without oral drugs.ClinicalTrials.gov Identifier: NCT01006291
- ORIGIN: Outcome reduction with Initial Glargine Intervention
A major global multicentric study to evaluate the effects of Insulin glargine in combination with omega 3 fatty acids in reducing CV morbidity and mortalityin people at high risk ot at early stages of diabetes.ClinicalTrials.gov Identifier: NCT00069784
- IDMPS: International Diabetes Management Practices Study – WAVE 5
An international, multicentric study to assess current practices in the management of type 1 and type 2 diabetes mellitus.