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Carotid Atherosclerosis: MEtformin for Insulin ResistAnce Study (CAMERA)
This study is not yet open for participant recruitment.
Verified by University of Glasgow, July 2008
Sponsors and Collaborators: University of Glasgow
NHS Greater Glasgow and Clyde
Chief Scientist Office
Information provided by: University of Glasgow
ClinicalTrials.gov Identifier: NCT00723307
  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: We 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, we will carry out ultrasound scans of the big blood vessels in the neck at the start of the study, after 1 year and after 2 years of therapy.We will then be able to assess whether metformin has had a beneficial impact.


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

MedlinePlus related topics: Coronary Artery Disease Diabetes Heart Diseases
Drug Information available for: Insulin Metformin Metformin hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

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: 2 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: 2 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: 2 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: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: October 2008
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Metformin
White film-coated tablets, 850mg tablet twice daily, 2 years duration
2: Placebo Comparator Drug: Placebo
White coated tablet; one tablet twice daily; 2 years duration

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

Contacts
Contact: Naveed Sattar, PhD +44 141 3303419 nsattar@clinmed.gla.ac.uk

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

Responsible Party: University of Glasgow, BHF Glasgow Cardiovascular Research Centre ( Professor Naveed Sattar )
Study ID Numbers: Gla-Met-1
Study First Received: July 24, 2008
Last Updated: July 24, 2008
ClinicalTrials.gov Identifier: NCT00723307  
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Study placed in the following topic categories:
Atherosclerosis
Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Metformin
Diabetes Mellitus
Disease Progression
Vascular Diseases
Central Nervous System Diseases
Arteriosclerosis
Ischemia
Brain Diseases
Cerebrovascular Disorders
Insulin
Coronary Disease
Insulin Resistance
Carotid Artery Diseases
Coronary Artery Disease

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Nervous System Diseases
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009