Effects of metformin and lifestyle modifications on the progression of the atherosclerosis among individuals with impaired glucose tolerance
Phase 3
Recruiting
- Conditions
- Pre-diabetes
- Registration Number
- SLCTR/2016/026
- Lead Sponsor
- niversity Grants Commission, Sri Lanka
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Intervention groups
1.Males and females aged > 20 years
2.Oral Glucose Tolerance Test (OGTT) 2 hrs value: between 140 and 199 mg/dl
Reference group
1.Males and females aged > 20 years
2.Oral Glucose Tolerance Test (OGTT) 2 hrs value: < 140 mg/dL
Exclusion Criteria
1. Pregnancy
2. Diagnosed diabetes mellitus or diagnosed by screening test OGTT 2 hr value: > 200 mg/dL
3. Manifested vascular disease such as ischemic heart disease, peripheral vascular disease or cerebrovascular disease
4. Patients already on drugs to modify the vascular risk factors, Eg: • anti-platelets • anti anginals • statins or lipid lowering drugs • folic acid • anti-inflammatory drugs • anticoagulants
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Surrogate markers for the progression of atherosclerosis<br><br>1.CIMT (carotid artery intima media thickness)<br><br>2.Lipid profile<br> [At baseline, 6 months, 12 months and 18 months after commencement of the intervention]<br>
- Secondary Outcome Measures
Name Time Method 1. HbA1c<br>2. Hs CRP (high sensitivity C-reactive protein) <br>3. ECG <br>4. ABI (Ankle brachial pressure index) <br>5. Blood pressure measurement<br>6. Anthropometric measurements and BMI (body mass index)<br><br> [At baseline, 6 months, 12 months and 18 months after commencement of the intervention]<br>