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Home » Trials » SLCTR/2016/026

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

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SLCTR Registration Number

SLCTR/2016/026

Date of Registration

25 Oct 2016

The date of last modification

Mar 03, 2019


Application Summary

Scientific Title of Trial

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

Public Title of Trial

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

Disease or Health Condition(s) Studied

Pre-diabetes

Scientific Acronym

None

Public Acronym

None

Brief title

None

Universal Trial Number

U1111-1183-4418

Any other number(s) assigned to the trial and issuing authority

9.3.16:4.1 (ERC: Ruhuna)


Trial Details

What is the research question being addressed?

What is the effect of metformin and a life style modification intervention on the progression of atherosclerosis and the glycaemic control among groups of individuals with impaired glucose tolerance?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Masking not used

Control

Standard therapy/practice

Assignment

Parallel

Purpose

Prevention

Study Phase

Phase 3

Intervention(s) planned

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

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

Primary outcome(s)

1.

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 outcome(s)

1.
  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

]

Target number/sample size

150 (30 in each arm)

Countries of recruitment

Sri Lanka

Anticipated start date

2016-10-25

Anticipated end date

2017-10-25

Date of first enrollment

2017-01-17

Date of study completion

Recruitment status

Recruiting

Funding source

University Grants Commission (Ref: UGC/DRIC/PG/2015(ii)/RUH/01)

Regulatory approvals


State of Ethics Review Approval

Status

Approved

Date of Approval

2016-03-09

Approval number

9.3.16:4.1

Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Ruhuna
Institutional Address:PO Box 70, Labuduwa Rd, Galle, Sri Lanka
Telephone:+94-91-2234801/803 (Extension: 161)
Email: ethics@med.ruh.ac.lk

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Dr. A.T. Isuru Madushika Amarasinghe
Lecturer (Probationary)
Faculty of Medicine University of Ruhuna Galle
Tel: 0912246877
Mobile: 0772332651

amarasingheisuru@yahoo.com

Contact Person for Public Queries

Professor Sarath Lekamwasam
Dean and Senior Professor in Medicine
Faculty of Medicine University of Ruhuna Galle
Tel: 091 2234801,091 2234803
Mobile: 0777275360
Fax: 091 2222314
slekamwasam@gmail.com

Primary study sponsor/organization

University Grants Commission, Sri Lanka

University Grants Commission No 20 Ward Place Colombo 07
Tel: 0112695301
fax; 0112688045

www.ugc.ac.lk

Secondary study sponsor (If any)

None





Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Not available

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available

No

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results


  • Trial Options