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Sponsored by: |
National Institute on Aging (NIA) |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00105066 |
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).
Condition | Intervention | Phase |
---|---|---|
Obesity Hypertension Hypercholesterolemia Hyperglycemia |
Drug: Metformin Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | The Effects of Metformin on Vascular Structure and Function in Subjects With the Metabolic Syndrome (MET Trial) |
Enrollment: | 70 |
Study Start Date: | January 2004 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Metformin
850mg tablet once a day for one month, then twice a day for 3 months
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2: Placebo Comparator |
Drug: Placebo
placebo tablet once a day for one month, then twice a day for 3 months
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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:
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.
Ages Eligible for Study: | 21 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Participants with the Metabolic Syndrome, which is defined as having 3 or more of the following 5 alterations:
Exclusion Criteria:
United States, Maryland | |
National Institute on Aging (NIA), Harbor Hospital | |
Baltimore, Maryland, United States, 21225 |
Principal Investigator: | Samer S. Najjar, MD | Staff Clinician - NIA, NIH |
Responsible Party: | National Institute on Aging, National Institutes of Health ( Samer S. Najjar, MD, Staff Clinician ) |
Study ID Numbers: | AG0017 |
Study First Received: | March 3, 2005 |
Last Updated: | August 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00105066 |
Health Authority: | United States: Federal Government |
Metabolic Syndrome triglycerides HDL LDL |
High Blood Pressure High Cholesterol High Blood Sugar |
Obesity Hyperlipidemias Metabolic Diseases Metformin Vascular Diseases Overweight Body Weight Signs and Symptoms Hyperglycemia |
Nutrition Disorders Overnutrition Metabolic disorder Glucose Metabolism Disorders Hypercholesterolemia Dyslipidemias Hypertension Lipid Metabolism Disorders |
Hypoglycemic Agents Physiological Effects of Drugs Cardiovascular Diseases Pharmacologic Actions |