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Carotid Atherosclerosis: MEtformin for Insulin ResistAnce Study

NCT00723307 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2012-12-11

No results posted yet for this study

Summary

Hypothesis: Treatment with metformin in overweight non-diabetic individuals with coronary heart disease and on standard cardiovascular risk reducing agents including statins will have a beneficial impact on carotid artery atherosclerosis compared to placebo.

Rationale: Once subjects have a heart attack, they remain at much higher than average risk of another heart attack and stroke, despite the best current therapies to lower their cholesterol and blood pressure and thin their blood. Many subjects with heart disease also have problems metabolising (i.e. processing) sugar even if they do not have diabetes. There is some evidence that metformin, a drug which improves sugar metabolism, decreases the risk of future heart attacks in diabetic patients. However, whether metformin further reduces the risk of heart disease beyond established treatments in people without diabetes is unknown.

Method: The investigators will test the ability metformin, a drug with proven safety, to slow the progression of furring up (known as atherosclerosis) of blood vessels in non-diabetic subjects with heart disease. This will be achieved by treating 2 groups of subjects with metformin and placebo pills respectively. To measure atherosclerosis, the investigators will carry out ultrasound scans of the big blood vessels in the neck at the start of the study, after 1 year and after 1.5 years of therapy.The investigators will then be able to assess whether metformin has had a beneficial impact.

Conditions

Interventions

DRUG

Metformin

White film-coated tablets, 850mg tablet twice daily, 1.5 years duration

DRUG

Placebo

White coated tablet; one tablet twice daily; 1.5 years duration

Sponsors & Collaborators

  • NHS Greater Glasgow and Clyde

    collaborator OTHER

  • Chief Scientist Office of the Scottish Government

    collaborator OTHER_GOV

  • Professor Naveed Sattar

    lead OTHER

Principal Investigators

  • Naveed Sattar, PhD · University of Glasgow

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00723307 on ClinicalTrials.gov