Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
NCT ID:
NCT00105066
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 (\<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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT00105066
Study Brief:
Protocol Section:
NCT00105066