The Effects of Metformin on Blood Vessel Structure and Function
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effects of Metformin on Vascular Structure and Function in Subjects With the Metabolic Syndrome (MET Trial)|
- decrease in arterial stiffness [ Time Frame: 4.5 months ] [ Designated as safety issue: No ]
- improvement in endothelial function [ Time Frame: 4.5 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2004|
|Study Completion Date:||May 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
850mg tablet once a day for one month, then twice a day for 3 months
Other Name: Fortamet®; Glucophage®; Glumetza™; Riomet™
|Placebo Comparator: 2||
placebo tablet once a day for one month, then twice a day for 3 months
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00105066
|United States, Maryland|
|National Institute on Aging (NIA), Harbor Hospital|
|Baltimore, Maryland, United States, 21225|
|Principal Investigator:||Luigi Ferrucci, MD||National Institute on Aging (NIA)|