Carotid Atherosclerosis: MEtformin for Insulin ResistAnce Study

NCT00723307 | Completed Phase 4

• 1 other identifier: Gla-Met-1 (version 5)
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 1

Brief 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

Coronary Artery Disease

Keywords

No diabetes mellitus; Elevated waist circumference

Outcome Measures

Primary Outcomes (1)

• Difference in progression of carotid intima-media thickness (measured in millimetres) between groups treated with metformin and placebo

  1.5 years

Secondary Outcomes (3)

• Correlation of HbA1C, t-PA, CRP, IL-6, HOMA-IR and ICAM-1 with change in carotid IMT in metformin- and placebo-treated groups will be evaluated.

  1.5 years

• Difference in progression of carotid total plaque area (measured in square millimetres) between groups treated with metformin and placebo

  1.5 years

• Difference in progression of carotid total plaque volume (measured in cubic millimetres) between groups treated with metformin and placebo

  1.5 years

Study Arms (2)

Metformin

EXPERIMENTAL

Drug: Metformin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Metformin DRUG

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

Also known as: Glucophage, Glucophage SR, Bolamyn SR

Metformin

Placebo DRUG

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

Also known as: Dummy pill

Placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Proven coronary heart disease (prior acute coronary syndrome, prior CABG or angiographically proven CHD)
• Aged 35-75 years
• Elevated waist circumference as per the International Diabetes Foundation criteria (94 cm in men and 80 cm in women)
• All patients will be on statin

You may not qualify if:

• Pregnancy and/or lactation at screening
• Premenopausal woman not on contraception
• Known or newly diagnosed diabetes mellitus on oral glucose tolerance testing (OGTT will be performed on subjects with HbA1C 6.0-6.9% and fasting plasma glucose \[FPG\] \< 7.0 mmol/L at screening18)
• Screening results: HbA1C ≥ 7.0% and/or fasting plasma glucose ≥ 7.0 mmol/L
• Patients with Acute Coronary Syndrome within the last 3 months
• Clinically unstable heart failure
• Uncontrolled angina
• Contraindications to metformin

Sponsors & Collaborators

• Professor Naveed Sattar: lead
• NHS Greater Glasgow and Clyde: collaborator
• Chief Scientist Office of the Scottish Government: collaborator

Study Sites (1)

Glasgow Clinical Research Facility, NHS Greater Glasgow and Clyde

Glasgow, G11 6NT, United Kingdom

Location

Related Publications (2)

• Preiss D, Welsh P, Sattar N. Metformin Therapy and Circulating NT-proBNP Levels: The CAMERA Trial. Diabetes Care. 2016 Aug;39(8):e114-5. doi: 10.2337/dc16-0887. Epub 2016 Jun 6. No abstract available.

  PMID: 27271181 DERIVED

• Preiss D, Lloyd SM, Ford I, McMurray JJ, Holman RR, Welsh P, Fisher M, Packard CJ, Sattar N. Metformin for non-diabetic patients with coronary heart disease (the CAMERA study): a randomised controlled trial. Lancet Diabetes Endocrinol. 2014 Feb;2(2):116-24. doi: 10.1016/S2213-8587(13)70152-9. Epub 2013 Nov 7.

  PMID: 24622715 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Metformin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Naveed Sattar, PhD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Metabolic Medicine

Study Record Dates

• First Submitted: July 24, 2008
• First Posted: July 28, 2008
• Study Start: February 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 11, 2012

Record last verified: 2012-12

Locations

GB (1)