Status:
COMPLETED
The Effects of Metformin on Blood Vessel Structure and Function
Lead Sponsor:
National Institute on Aging (NIA)
Conditions:
Obesity
Hypertension
Eligibility:
All Genders
21-80 years
Phase:
PHASE2
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00105066
Start Date
January 1 2004
End Date
May 1 2008
Last Update
January 18 2017
Active Locations (1)
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1
National Institute on Aging (NIA), Harbor Hospital
Baltimore, Maryland, United States, 21225