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 @ 1:03 PM
Ignite Modification Date:
2025-12-24 @ 1:03 PM
NCT ID:
NCT00220961
Eligibility Criteria:
Inclusion Criteria:
* Men and women
* All ethnic groups
* 18 years of age and older
* Impaired glucose tolerance by glucose tolerance test (fasting glucose 95-125 mg/dl and 2 hr glucose of 140-199 mg/dl)
* At least one of the following:
* One or more components of the insulin resistance syndrome (HDL \< 40 mg/dl in females and \<35 mg/dl in males, fasting triglycerides \> 150 mg/dl, blood pressure \> 135/85 mmHg, BMI \> 24 kg/m2, waist circumference \> 102 cm in men and \> 88 cm in women)
* One or more first degree relatives with type 2 diabetes
* History of gestational diabetes
* Polycystic ovarian disease
* Minority ethnic background (Mexican American, African American, Asian and Pacific Islanders, Native American)
Exclusion Criteria:
* Type 2 diabetes
* Previously treated with thiazolidinediones (ever) or metformin (within one year)
* Previously treated with a sulfonylurea, a meglitinide, an alpha glucosidase inhibitor for more than a week within last year or within the 3 months prior to randomization
* Previously treated with insulin (other than during pregnancy) for more than one week within the last year or within the 3 months prior to randomization
* Cardiovascular disease
* Hospitalization for treatment of heart disease or stroke in past 6 months
* New York Heart Association Functional Class \> 2
* Left bundle branch block or third degree AV block
* Aortic stenosis
* SBP \> 180 mmHg or DBP \> 105 mmHg
* Renal disease
* Anemia
* Hepatitis
* GI diseases (pancreatitis, inflammatory bowel disease)
* Recent or significant abdominal surgery
* Advanced pulmonary disease
* Chronic infections
* Weight loss \> 10% in past 6 months
* Pregnancy and childbearing
* Major psychiatric disorders
* Excessive alcohol intake
* Thiazide use \> 25 mg per day
* Non-selective beta blockers
* Niacin
* Systemic glucocorticoids
* Weight loss or weight gain medication
* Thyroid disease-suboptimally treated
* Active endocrine diseases (Cushing's, acromegaly)
* Plasma triglycerides over 400 mg/dl (despite treatment)
* History bladder cancer
* Hematuria
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00220961
Study Brief:
Protocol Section:
NCT00220961