The Effects of Metformin on Blood Vessel Structure and Function

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate whether the drug Metformin has beneficial effects on the blood vessels of individuals with the Metabolic Syndrome (MeS).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute on Aging (NIA)
• Treatments: Metformin

Criteria

Inclusion Criteria:

Participants with the Metabolic Syndrome, which is defined as having 3 or more of the following 5 alterations:

• Abdominal obesity (waist measurement >39.8 inches in men, >34.4 inches in women)

• Elevated triglycerides (>150 mg/dl)

• Low HDL or "good" cholesterol (<40 mg/dl in men or <50 mg/dl in women)

• Elevated blood pressure (>130/85) or treatment for high blood pressure

• Elevated fasting blood sugar (>100 mg/dl)

Exclusion Criteria:

• Diabetes treated with medication

• Blood pressure >160/100 mmHg

• Clinical Congestive Heart Failure

• Anemia with hematocrit <32%

• Asthma or Chronic Obstructive Pulmonary Disease (COPD) requiring daily medication or use of home oxygen therapy

• Major surgery planned within the next six months

• A recent, unexplained weight loss of >10% of body weight in the past 6 months

• A known allergy or hypersensitivity to Metformin

• History of hepatitis or cirrhosis

• History of kidney disease (defined as serum creatinine >1.4 mg/dL in men, >1.3 mg/dL in women)

• Pregnancy or the absence of an effective method of contraception

• Illicit drug or alcohol abuse

• Cancer requiring treatment currently or recently completed treatment in the last 2 months