Original researchA model of translational research for diabetes prevention in low and middle-income countries: The Diabetes Community Lifestyle Improvement Program (D-CLIP) trial
Introduction
Effective implementation of evidence from proven clinical and public health interventions for diabetes prevention [1], [2], [3], [4], particularly in low and middle-income countries (LMIC), is a challenge. Translational research can identify the best ways to deliver successful prevention programs to communities. These trials of community-level implementation of proven policy should attempt to incorporate the standards for translational research and program dissemination [5], [6], [7], [8]; namely the integration of tools to measure program effectiveness, efficiency, reach, and community-level outcomes.
Herein, we describe the Diabetes Community Lifestyle Improvement Program (D-CLIP), which addresses the implementation issues of translational research to prevent diabetes in India, a large LMIC with a markedly high prevalence of Type 2 diabetes mellitus (T2DM) [9], [10], [11]. Based on the strength of the evidence for behavioral and pharmacological interventions for T2DM prevention [1], [2], [3], [4], [12], [13], [14], [15], expert groups such as the American Diabetes Association and the International Diabetes Federation promote the use of lifestyle programs first, followed by the appropriate addition of oral hypoglycaemic agents like metformin in individuals non-responsive to lifestyle change, for diabetes prevention in the larger at-risk population: individuals with impaired glucose tolerance (IGT), impaired fasting glucose (IFG), or both, a more encompassing group than those evaluated in efficacy studies. Because these policies are difficult and costly to implement and scale up in their tested forms, the level of real-world implementation is rudimentary. D-CLIP tests the effectiveness of implementing these policies (lifestyle plus metformin when necessary) in a wide range of individuals at risk for developing diabetes, including those with IFG, IGT or both, in a LMIC setting.
Section snippets
Study participants
Inclusion and exclusion criteria for D-CLIP were selected to minimize the risk of adverse events while reaching the broadest population of individuals with pre-diabetes. Men and women, aged 20–65 years with no major concomitant health issues who are overweight (using South Asian-appropriated cut-points defined by the World Health Organization [16], a Body Mass Index, BMI, of ≥23 kg/m2 and/or a waist circumference ≥90 cm for men and ≥80 cm for women) and are at high risk of developing T2DM because
Discussion
Both lifestyle change and metformin have been described as highly efficacious and cost-effective methods for diabetes prevention in clinical trials [1], [4], [29], [30]; however, the use of metformin for highest risk individuals, added step-wise in conjunction with lifestyle intervention, has not been tested in a community-based trial. The D-CLIP study uses a step-wise model of diabetes prevention where participants attend four months of diet, exercise, and weight loss education, and,
Conflict of interest statement
The authors have no conflict of interest to declare.
Acknowledgements
This project is supported by a BRiDGES Grant from the International Diabetes Federation. BRiDGES, an International Diabetes Federation project, is supported by an educational grant from Eli Lilly and Company. The researchers would also like to acknowledge the support provided by the Global Health Institute at Emory University, and M/s. USV India Ltd. for donating the Metformin used in the D-CLIP study. We thank Dr. RM Anjana and the health educators, fitness consultants and the field team of
References (42)
- et al.
The long-term effect of lifestyle interventions to prevent diabetes in the China Da Qing Diabetes Prevention Study: a 20-year follow-up study
Lancet
(2008) - et al.
Sustained reduction in the incidence of type 2 diabetes by lifestyle intervention: follow-up of the Finnish Diabetes Prevention Study
Lancet
(2006) - et al.
Prevention of type 2 diabetes by lifestyle intervention: a Japanese trial in IGT males
Diabetes Res. Clin. Pract.
(2005) - et al.
Normal fasting plasma glucose and risk of type 2 diabetes diagnosis
Am. J. Med.
(2008) - et al.
Alma-Ata: rebirth and revision 6 interventions to address maternal, newborn, and child survival: what difference can integrated primary health care strategies make?
Lancet
(2008) - et al.
Perceived environmental aesthetics and convenience and company are associated with walking for exercise among Australian adults
Prevent. Med.
(2001) - et al.
Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin
N. Engl. J. Med.
(2002) - et al.
The Finnish Diabetes Prevention Study (DPS): lifestyle intervention and 3-year results on diet and physical activity
Diabetes Care
(2003) - et al.
Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study
Diabetes Care
(1997) - et al.
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)
A clinician's guide to cost-effectiveness analysis
Ann. Intern. Med.
Considerations for diabetes translational research in real-world settings
Diabetes Care
Translation research for chronic disease: the case of diabetes
Diabetes Care
A translational framework for public health research
BMC Public Health
Body composition, visceral fat, leptin, and insulin resistance in Asian Indian men
J. Clin. Endocrinol. Metab.
Secular trends in the prevalence of diabetes and impaired glucose tolerance in urban South India--the Chennai Urban Rural Epidemiology Study (CURES-17)
Diabetologia
IDF Diabetes Atlas
10-Year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study
Lancet
Appropriate body-mass index for Asian populations and its implications for policy and intervention strategies
Lancet
Standards of medical care in diabetes – 2010
Diabetes Care
The Diabetes Prevention Program's Lifestyle Change Program, Manual of Operations
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