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

INTERVENTION: 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. Participants with selected criteria will be allocated to different arms by using block randomization method. (One block will consist of 4 participants) Patients with impaired glucose tolerance will be allocated to three separate test arms (1‐3) and one control arm (4). Arm 1: Subjects with impaired glucose tolerance on metformin ( metformin 500mg sustained release tablet daily for 6 months) Arm 2: Subjects with impaired glucose tolerance on pre‐designed exercise program for 6 months Arm 3: Subjects with impaired glucose tolerance on both metformin and pre‐designed exercise program for 6 months Arm 4: Subjects with impaired glucose tolerance on general medical advice for 6 months The exercise programme will include: moderate level seated aerobics, 150 minutes per week for a total of 6 months, to achieve 60‐75% of maximum tolerable heart rate for a patient. Exercise programme will be conducted by the principal investigator to a group of selected participants. Adherence and compliance will be monitored by maintaining the individual diary and monthly review. A randomly selected group of subjects with normal glucose tolerance will also be followed up as a reference group CONDITION: Pre‐diabetes PRIMARY OUTCOME: Surrogate markers for the progression of atherosclerosis; ; 1. CIMT (carotid artery intima media thickness); ; 2. Lipid profile; SECONDARY OUTCOME: 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) ; ; 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