Phase 2
Completed N=77
The Effects of Metformin on Blood Vessel Structure and Function
Source: ClinicalTrials.gov NCT00105066 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Change in Arterial Stiffness Compared to Baseline — -7.2; -7.3 meters / second
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Arterial Stiffness Compared to Baseline |
-7.2; -7.3 | — |
| PRIMARY Change in Flow Mediated Dilation (FMD) |
8.8; 10.5 | — |
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 ( 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 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
Data sourced from ClinicalTrials.gov (NCT00105066). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.