The Effects of Metformin on Blood Vessel Structure and Function | RxWiki

The Effects of Metformin on Blood Vessel Structure and Function

Overview[ - collapse ][ - ]

Purpose	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	Obesity Hypertension Hypercholesterolemia Hyperglycemia
Intervention	Drug: Metformin Drug: Placebo
Phase	Phase 2
Sponsor	National Institute on Aging (NIA)
Responsible Party	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier	NCT00105066
First Received	March 3, 2005
Last Updated	August 2, 2012
Last verified	August 2012

Tracking Information[ + expand ][ + ]

First Received Date	March 3, 2005
Last Updated Date	August 2, 2012
Start Date	January 2004
Estimated Primary Completion Date	May 2008
Current Primary Outcome Measures	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]
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	The Effects of Metformin on Blood Vessel Structure and Function
Official Title	The Effects of Metformin on Vascular Structure and Function in Subjects With the Metabolic Syndrome (MET Trial)
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.
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Obesity Hypertension Hypercholesterolemia Hyperglycemia
Intervention	Drug: Metformin 850mg tablet once a day for one month, then twice a day for 3 months Other Names: Fortamet®; Glucophage®; Glumetza™; Riomet™Drug: Placebo placebo tablet once a day for one month, then twice a day for 3 months
Study Arm (s)	Experimental: 1 Placebo Comparator: 2

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	70
Estimated Completion Date	May 2008
Estimated Primary Completion Date	May 2008
Eligibility 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
Gender	Both
Ages	21 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00105066
Other Study ID Numbers	AG0017
Has Data Monitoring Committee	No
Information Provided By	National Institutes of Health Clinical Center (CC)
Study Sponsor	National Institute on Aging (NIA)
Collaborators	Not Provided
Investigators	Principal Investigator: Luigi Ferrucci, MD National Institute on Aging (NIA)
Verification Date	August 2012

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