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The Effects of Metformin on Blood Vessel Structure and Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier:
NCT00105066
First received: March 3, 2005
Last updated: August 2, 2012
Last verified: August 2012
History of Changes

March 3, 2005
August 2, 2012
January 2004
May 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • decrease in arterial stiffness
  • improvement in endothelial function
Complete list of historical versions of study NCT00105066 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effects of Metformin on Blood Vessel Structure and Function
The Effects of Metformin on Vascular Structure and Function in Subjects With the Metabolic Syndrome (MET Trial)

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).

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Obesity
  • Hypertension
  • Hypercholesterolemia
  • Hyperglycemia
  • Drug: Metformin
    850mg tablet once a day for one month, then twice a day for 3 months
    Other Name: Fortamet®; Glucophage®; Glumetza™; Riomet™
  • Drug: Placebo
    placebo tablet once a day for one month, then twice a day for 3 months
  • Experimental: 1
    Intervention: Drug: Metformin
  • Placebo Comparator: 2
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
21 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00105066
AG0017
No
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
National Institute on Aging (NIA)
Not Provided
Principal Investigator: Luigi Ferrucci, MD National Institute on Aging (NIA)
National Institutes of Health Clinical Center (CC)
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP