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Effects of metformin and lifestyle modifications on the progression of the atherosclerosis among individuals with impaired glucose tolerance

Effects of metformin and lifestyle modifications on the progression of the atherosclerosis among individuals with impaired glucose tolerance

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2016/026
Enrollment
Unknown
Registered
2016-10-25
Start date
2016-10-25
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-diabetes

Interventions

Study setting: Galle district, Sri Lanka Recruitment: Subjects will be recruited from Galle district using the latest Voters’ register after applying the inclusion and exclusion criteria. Participant

Sponsors

University Grants Commission, Sri Lanka
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Surrogate markers for the progression of atherosclerosis 1.CIMT (carotid artery intima media thickness) 2.Lipid profile [At baseline, 6 months, 12 months and 18 months after commencement of the intervention]

Secondary

MeasureTime frame
1. HbA1c 2. Hs CRP (high sensitivity C-reactive protein) 3. ECG 4. ABI (Ankle brachial pressure index) 5. Blood pressure measurement 6. Anthropometric measurements and BMI (body mass index) [At baseline, 6 months, 12 months and 18 months after commencement of the intervention]

Countries

Sri Lanka

Contacts

Public ContactDr. A.T. Isuru Madushika Amarasinghe

Lecturer (Probationary)

amarasingheisuru@yahoo.comTel: 0912246877

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026