The long-term effectiveness of Kerala Diabetes Prevention Programme.
Not Applicable
- Registration Number
- CTRI/2021/10/037191
- Lead Sponsor
- HMRC Australia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Participants (age 30â??60 years) were those with an Indian Diabetes Risk Score (IDRS) >=60 and were free of diabetes on an oral glucose tolerance test (OGTT) and recruited seven years back as part of K-DPP study. A total of 1,007 participants (47.2% female) were enrolled (507 in the control group and 500 in the intervention group) in the K-DPP study. These participants will be followed-up at seven years.
Exclusion Criteria
Not Willing to provide written informed consent for the 7-year follow-up evaluation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage of participants with a 10-year CVD risk â?¥20% at 7-years.Timepoint: The percentage of participants with a 10-year CVD risk â?¥20% at 7-years.
- Secondary Outcome Measures
Name Time Method BP, weight, HbA1c, lipid prrfile, SF-36, tobacco, BMI, fat percent, muscle mass, waist circumference, FPG, 2- hr PG, current alcohol use, diet, and physical activity. New measures of pre-clinical micro vascular changes (retinal architecture) will also be assessed. Additional outcomes measures include serum creatinine, and urine albumin creatinine ratio. An ECG (12 lead) will be also taken at 7-years. Multimorbidity will be also considered as an outcome variable.Timepoint: 7-year assessment.