The Effects of Metformin on Blood Vessel Structure and Function

National Institutes of Health (NIH)

Status and phase

Completed

Phase 2

Conditions

Hypertension

Hyperglycemia

Hypercholesterolemia

Obesity

Treatments

Drug: Metformin

Drug: Placebo

Study type

Interventional

Funder types

NIH

Identifiers

NCT00105066

AG0017

Details and patient eligibility

About

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).

Full description

Individuals with the Metabolic Syndrome (MeS) are at increased risk for developing cardiovascular diseases. This increased risk may, in part, be related to abnormalities in the blood vessels. MeS is defined as having 3 or more of the following 5 criteria:

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)

Metformin is a medication that is approved by the Food and Drug Administration (FDA) for the treatment of diabetes; however, it can also be safely administered to non-diabetic subjects. We are evaluating whether Metformin reduces the stiffness of blood vessels and improves endothelial function.

This study requires 4 visits to the NIA Clinical Research Center (located on the premises of Harbor Hospital) over a 5-month period. At the initial visit, patients will be given a physical examination with blood and urine tests, and an EKG. They will be randomized into one of two groups; one group will receive Metformin (1700 mg per day), while the other group will receive a placebo. Participants will take the medication for 4 months. Subsequent visits will include additional blood tests, ultrasound and echo exams.

Taking part in this study is entirely voluntary. All testing and medications will be provided at no cost to the participant or their family.

Enrollment

77 patients

Sex

All

Ages

21 to 80 years old

Volunteers

No Healthy Volunteers

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