Carotid Atherosclerosis: MEtformin for Insulin ResistAnce Study (CAMERA)

This study has been completed.
Sponsor:
Collaborators:
NHS Greater Glasgow and Clyde
Chief Scientist Office of the Scottish Government
Information provided by (Responsible Party):
Professor Naveed Sattar, University of Glasgow
ClinicalTrials.gov Identifier:
NCT00723307
First received: July 24, 2008
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Drug: Metformin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by University of Glasgow:

Primary Outcome Measures:
  • Difference in progression of carotid intima-media thickness (measured in millimetres) between groups treated with metformin and placebo [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Difference in progression of carotid total plaque area (measured in square millimetres) between groups treated with metformin and placebo [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Difference in progression of carotid total plaque volume (measured in cubic millimetres) between groups treated with metformin and placebo [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Enrollment: 173
Study Start Date: February 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin Drug: Metformin
White film-coated tablets, 850mg tablet twice daily, 1.5 years duration
Other Names:
  • Glucophage
  • Glucophage SR
  • Bolamyn SR
Placebo Comparator: Placebo Drug: Placebo
White coated tablet; one tablet twice daily; 1.5 years duration
Other Name: Dummy pill

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723307

Locations
United Kingdom
Glasgow Clinical Research Facility, NHS Greater Glasgow and Clyde
Glasgow, United Kingdom, G11 6NT
Sponsors and Collaborators
Professor Naveed Sattar
NHS Greater Glasgow and Clyde
Chief Scientist Office of the Scottish Government
Investigators
Principal Investigator: Naveed Sattar, PhD University of Glasgow
  More Information

No publications provided by University of Glasgow

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Naveed Sattar, Professor of Metabolic Medicine, University of Glasgow
ClinicalTrials.gov Identifier: NCT00723307     History of Changes
Other Study ID Numbers: Gla-Met-1 (version 5)
Study First Received: July 24, 2008
Last Updated: December 7, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Glasgow:
No diabetes mellitus
Elevated waist circumference

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Carotid Artery Diseases
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Heart Diseases
Nervous System Diseases
Vascular Diseases
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014