Carotid Atherosclerosis: MEtformin for Insulin ResistAnce Study
Information source: University of Glasgow
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease
Intervention: Metformin (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Glasgow Official(s) and/or principal investigator(s):
Naveed Sattar, PhD, Principal Investigator, Affiliation: University of Glasgow
Overall contact:
Naveed Sattar, PhD, Phone: +44 141 3303419, Email: nsattar@clinmed.gla.ac.uk
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 2 years of therapy. The investigators will then be
able to assess whether metformin has had a beneficial impact.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Difference in progression of carotid intima-media thickness (measured in millimetres) between groups treated with metformin and placebo
Secondary outcome: 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.Difference in progression of carotid total plaque area (measured in square millimetres) between groups treated with metformin and placebo Difference in progression of carotid total plaque volume (measured in cubic millimetres) between groups treated with metformin and placebo
Eligibility
Minimum age: 35 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Naveed Sattar, PhD, Phone: +44 141 3303419, Email: nsattar@clinmed.gla.ac.uk
Glasgow Clinical Research Facility, NHS Greater Glasgow and Clyde, Glasgow G11 6NT, United Kingdom; Recruiting
Anne Gordon, Email: anne.gordon2@ggc.scot.nhs.uk
Additional Information
Starting date: February 2009
Ending date: August 2011
Last updated: February 17, 2009
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