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 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT00198757
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-65 years of age.
2. Overweight (Body Mass Index between 25-40) and desiring weight loss
3. Normal ECG (electrocardiogram) or abnormalities deemed medically acceptable (no acute ischemic changes or V-tach, eg)
4. Not using appetite-affecting medications (e.g., Prozac or other SSRIs, synthroid, steroids) unless on established and stable dose
5. Not using weight loss drugs (phentermine, sibutramine, orlistat, eg)
6. Willing and able to comply with the protocol requirements
7. Willing and able to give informed consent
8. Have a regular source of health care and permission of primary care provider
9. Using an acceptable method of birth control (tubal ligation, abstinence, properly used condom or diaphragm, oral or implanted contraceptives, or intrauterine device) for women of childbearing potential
Exclusion Criteria:
1. Chronic uncontrolled health problems (not including obesity and diabetes). Participants may not have bulimia, laxative abuse, substance abuse, alcohol intake \> 10 drinks per week, or have an uncontrolled psychiatric disorder (major depression, bipolar disorder, etc), as determined at screening
2. Breast-feeding or pregnant at screening by serum pregnancy test if female of childbearing capacity. To be considered not childbearing potential, participant must be at least one year post-menopausal or surgically sterile
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00198757
Study Brief:
Protocol Section:
NCT00198757