The Effects of Metformin on Blood Vessel Structure and Function - Tabular View

Tracking Information

First Received Date ^ICMJE

March 3, 2005

Last Updated Date

August 28, 2008

Start Date ^ICMJE

January 2004

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

decrease in arterial stiffness
improvement in endothelial function

Change History

Complete list of historical versions of study NCT00105066 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

The Effects of Metformin on Blood Vessel Structure and Function

Official Title ^ICMJE

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Obesity
Hypertension
Hypercholesterolemia
Hyperglycemia

Intervention ^ICMJE

Drug: Metformin
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00105066

Responsible Party

Samer S. Najjar, MD, Staff Clinician, National Institute on Aging, National Institutes of Health

Study ID Numbers ^ICMJE

AG0017

Study Sponsor ^ICMJE

National Institute on Aging (NIA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Samer S. Najjar, MD

Staff Clinician - NIA, NIH

Information Provided By

National Institute on Aging (NIA)

Verification Date

August 2008

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