A Randomized Trial of Diabetes Prevention Through Lifestyle Change in India
Launched by EMORY UNIVERSITY · Jan 24, 2011
Trial Information
Current as of April 09, 2025
Completed
Keywords
ClinConnect Summary
Aims: The Diabetes Community Lifestyle Improvement Program (D-CLIP) aims to implement and evaluate in a controlled, randomized trial the effectiveness, cost-effectiveness, and sustainability of a culturally appropriate, low-cost, and sustainable lifestyle intervention for the prevention of type 2 diabetes mellitus in India.
Methods: D-CLIP, a translational research project adapted from the methods and curriculum developed and tested for efficacy in the Diabetes Prevention Program, utilizes innovated methods (a step-wise model of diabetes prevention with lifestyle and metformin added when n...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Live in or near Chennai, India
- • Aged 20-65 years
- • A BMI \>22 kg/m2 and/or a waist circumference \>90 cm for men and \>80 cm for women
- • No prior diabetes diagnosis, except for gestational diabetes
- • At high risk of developing diabetes (pre-diabetes) as defined by a casual capillary glucose greater than or equal to 110 (measured during screening) AND Baseline fasting glucose of 100-125 mg/dL and/or 2-hour post-load glucose of 140-199 mg/dL
- • Willingness to consent to randomization
- Exclusion Criteria:
- • Does not fulfill inclusion criteria
- • Currently pregnant or breastfeeding
- • History of or biomarkers indicating heart disease, serious illness, cancer diagnosis in the past 5 years, or other conditions that may impede or prohibit participation in an unsupervised diet change and physical activity program.
Trial Officials
Viswanathan Mohan, MD, PhD
Principal Investigator
Madras Diabetes Research Foundation/Dr. Mohan's Diabetes Specialities Centre
K.M. Venkat Narayan, MD
Principal Investigator
Emory University
About Emory University
Emory University, a leading research institution located in Atlanta, Georgia, is dedicated to advancing medical knowledge and improving patient care through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, Emory harnesses the expertise of its renowned faculty and state-of-the-art facilities to conduct cutting-edge research across various fields, including oncology, neurology, and infectious diseases. The university's commitment to ethical research practices and patient safety ensures that all clinical trials are designed to generate valuable data that can lead to significant therapeutic advancements. By fostering partnerships with local hospitals and community organizations, Emory strives to translate research findings into real-world applications, ultimately enhancing health outcomes for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chennai, Tamil Nadu, India
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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