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
  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 Intervention Phase
Obesity
Hypertension
Hypercholesterolemia
Hyperglycemia
Drug: Metformin
Drug: Placebo
Phase 2

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

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 ]

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
Experimental: 1 Drug: Metformin
850mg tablet once a day for one month, then twice a day for 3 months
Other Name: Fortamet®; Glucophage®; Glumetza™; Riomet™
Placebo Comparator: 2 Drug: Placebo
placebo tablet once a day for one month, then twice a day for 3 months

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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105066

Locations
United States, Maryland
National Institute on Aging (NIA), Harbor Hospital
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Investigators
Principal Investigator: Luigi Ferrucci, MD National Institute on Aging (NIA)
  More Information

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier: NCT00105066     History of Changes
Other Study ID Numbers: AG0017
Study First Received: March 3, 2005
Last Updated: August 2, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Metabolic Syndrome
triglycerides
HDL
LDL
High Blood Pressure
High Cholesterol
High Blood Sugar

Additional relevant MeSH terms:
Hypertension
Hypercholesterolemia
Hyperglycemia
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Glucose Metabolism Disorders
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014