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 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT00845559
Eligibility Criteria:
Obese subjects:
Major Inclusion Criteria:
* Obesity (BMI \> 97%tile for age and sex matched normative data)
* Insulin resistance: fasting insulin\> 25 mIU/ml
* Good general health, taking no medication on a chronic basis
* Age 16-25 yrs, late pubertal stage (girls: breast: Tanner stage IV to V, boys: testicular volume \> 15 ml) or age 13-15 yrs (with a family history of type 2 diabetes, whom have completed or reached tanner stage III and have impaired oral glucose tolerance with a 2-hour glucose of 180-199 mg/dl)
* Girls who are sexually active must use adequate birth control methods (such as barrier method or oral contraception) and must have a negative pregnancy test
* Normal liver function tests
Major Exclusion Criteria:
* Hx of gallstones
* Elevated triglycerides \>400 mg/dl
* Hx of alcohol use/ binge drinking
* Raynaud's syndrome
* Pregnancy or breastfeeding mothers
* Cigarette smokers
* Anemia (Hct \< 35)
* Baseline creatinine \> 1.0 mg
* Abnormal liver transaminases \> 2.0 X the upper limit of normal
* Presence of endocrinopathies except for adequately treated hypothyroidism
* Presence or history of gastrointestinal disorders (inflammatory bowl disease, irritable bowl disease, hernia, ileus)
* Presence of significant chronic illness of any kind.
* Use of any drugs that might be expected to affect glucose tolerance, insulin resistance or weight gain, cardiovascular health.
* Psychiatric disorders
* History of substance abuse
Lean Control Subjects (only for cardiovascular studies and CGMS):
Inclusion Criteria:
* Lean (BMI \< 85%tile for age and sex matched normative data)
* Fasting insulin \<15 mIU/m
* Fasting glucose \<100 mg/dll
* Excellent general health, having no acute or chronic health problems and taking no current medications
* Age 13-25 yrs, in puberty (age matched with obese subjects)
* Girls who are sexually active must use adequate birth control methods (such as barrier method or oral contraception) and must have a negative pregnancy test
Exclusion Criteria:
* Raynaud's syndrome
* Pregnancy or breastfeeding mothers
* Cigarette smokers
* Psychiatric disorders
* History of substance abuse
* First degree relative with either T1DM or T2DM
* Presence of acanthosis nigricans
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
25 Years
Study:
NCT00845559
Study Brief:
Protocol Section:
NCT00845559