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:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT00200720
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) of 27 to 50
* Fasting glucose less than 126 mg/dl
* Total fasting cholesterol less than 260 mg/dl
* Total fasting triglycerides less than 400 mg/dl
* Permission of primary care provider to participate in the study
* Normal liver and kidney function
* Willing to modify diet and other health behaviors
* Willing to use an acceptable method of contraception for the duration of the study
Exclusion Criteria:
* Any medical condition that may make weight loss medically inadvisable
* Weigh more than 400 lbs
* History of kidney failure
* Current use of more than 3 blood pressure medications
* Change in blood pressure medications within 3 months prior to study entry
* Diagnosis of cardiovascular disease within 6 months prior to study entry
* Cancer diagnosis within 2 years of study entry. Participants with basal cell skin cancer are not excluded.
* History of psychiatric hospitalization within 2 years prior to study entry
* Consumption of more than three alcoholic drinks a day
* Type I or II diabetes
* Current use of hypolipidemics, antipsychotics, hypoglycemics, glucocorticoids, or thyroid medication
* Plan to move during study
* Current participation in another clinical trial
* Pregnancy or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT00200720
Study Brief:
Protocol Section:
NCT00200720