Kerala Diabetes Prevention Program (K-DPP): A cluster RCT trial of its effectiveness and cost-effectiveness

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Cardiovascular Disease; Public Health - Epidemiology; Metabolic and Endocrine - Diabetes; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12611000262909
• Lead Sponsor: Baker Heart and Diabetes Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-10
• Study Completion: 2023-06-27
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1007

Inclusion Criteria

Consenting males and females on the electoral roll from the 60 selected polling booths; Consenting males and females on the electoral roll from the 60 selected polling booths

Exclusion Criteria

Prior diagnosis of T2DM or history of other major illnesses; Current use of medication known to affect glucose tolerance; Mental illness; Pregnancy; Illiteracy; Indian Diabetes Risk Score <55; 2 hr plasma glucose of greater than or equal to 11.1 mmol/l; Fasting plasma glucose greater than or equal to 7.0 mmol/l; Prior diagnosis of T2DM or history of other major illnesses; Current use of medication known to affect glucose tolerance; Mental illness; Pregnancy; Illiteracy; Indian Diabetes Risk Score <55; 2 hr plasma glucose of greater than or equal to 11.1 mmol/l; Fasting plasma glucose greater than or equal to 7.0 mmol/l

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Type 2 Diabetes Incidence (assessed using blood tests and oral glucose tolerance tests to measure fasting plasma glucose and 2 hour post-load glucose)[ the primary timepoint will be baseline, 12 months, 24 months and 8 years. ];10-year predicted CVD risk based on Indian Diabetes Risk Score (IDRS)[ Baseline, 12 months,24 months and 8 years ];Type 2 Diabetes Incidence (assessed using blood tests and oral glucose tolerance tests to measure fasting plasma glucose and 2 hour post-load glucose)[ the primary timepoint will be baseline, 12 months, 24 months and 8 years. ];10-year predicted CVD risk based on Indian Diabetes Risk Score (IDRS)[ Baseline, 12 months,24 months and 8 years ]