Conditions: Obesity Hypertension Hypercholesterolemia Hyperglycemia
Keywords: Metabolic Syndrome triglycerides HDL LDL High Blood Pressure High Cholesterol High Blood Sugar
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 77
Healthy volunteers: no

Brief 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).

Detailed 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.

Arms:
arm 1: placebo arm 2: Metformin 850 mg twice daily

Interventions: intervention 1: Metformin intervention 2: Placebo
Intervention descriptions: intervention 1: 850mg tablet once a day for one month, then twice a day for 3 months intervention 2: placebo tablet once a day for one month, then twice a day for 3 months

Protocol document: