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 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT00850356
Eligibility Criteria:
Inclusion Criteria:
1. 18-60 years old
2. Male and Female
3. BMI Levels greater than or equal to 35 kg/m2 and a major medical comorbidity OR BMI levels greater than or equal to 40 kg/m2
4. Able to provide written informed consent
Exclusion Criteria:
1. Pregnant or nursing
2. Previously enrolled in this study (e.g Community Control Arm)
3. Currently participating in a clinical trial
4. Individual expected to have difficulty with follow-up visits, completion of questionnaires, etc.
5. Any contraindications to bariatric surgery and/or anti-obesity medical treatment
6. Ability and willingness to complete questionnaires.
7. Any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the study protocol.
8. Patients in whom protein sparing very low calorie diet therapy is planned.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00850356
Study Brief:
Protocol Section:
NCT00850356