A study to assess the effect of a combination of glucose lowering medicines in prevention of type 2 diabetes among women with previous history of gestational diabetes mellitus and having pre-diabetes
Not Applicable
- Registration Number
- CTRI/2024/05/067588
- Lead Sponsor
- Indian Council of Medical Research (ICMR)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Most recent pregnancy affected by GDM within past 60 months 2. Currently diagnosed to be pre-diabetic
Exclusion Criteria
1. Pregnancy planned or inadequate contraception
2. Currently pregnant or lactating
3. Established Type 2 Diabetes Mellitus
4. Known renal insufficiency, liver disease and/or anaemia
5. Intolerance to either metformin or vildagliptin
6. Other indication of metformin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of women who develop type 2 diabetes mellitus, at or prior to final visit (based on oral glucose tolerance test)Timepoint: At 6 months, 12 months, 18 months, 24 months
- Secondary Outcome Measures
Name Time Method Proportion of women with change in glycaemic category to normal glucose tolerance (based on Oral Glucose Tolerance Test), BMI, Waist circumference, Health-related quality of life, Treatment tolerabilityTimepoint: At 6 months, 12 months, 18 months, 24 months