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Completed

NCT Number: NCT00723307

Carotid Atherosclerosis: MEtformin for Insulin ResistAnce Study

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.

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Key information

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Glasgow Clinical Research Facility, NHS Greater Glasgow and Clyde

Glasgow, G11 6NT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

metformin

Drug

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

Other names: Glucophage, Glucophage SR, Bolamyn SR

Placebo

Drug

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

Other names: Dummy pill

Primary outcomes

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

    Time frame: 1.5 years

Secondary outcomes

  1. 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.

    Time frame: 1.5 years

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

    Time frame: 1.5 years

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

    Time frame: 1.5 years

Sponsors and collaborators

Lead sponsor

Professor Naveed Sattar

Other

Collaborators

  • Chief Scientist Office of the Scottish Government
  • NHS Greater Glasgow and Clyde

Registry information

Official study title

A Randomised Placebo-controlled Trial of Metformin on Progression of Carotid Atherosclerosis in Non-diabetic Patients With Cardiovascular Disease Treated With Conventional Risk Reducing Agents

Acronym: CAMERA

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 28, 2008
Registry last updated
Dec 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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