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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT01288456
Eligibility Criteria:
Inclusion Criteria:
1. Age between 21-64 years
2. BMI 27-40 Kg/m2
3. No history of weight reduction of more than 5% of total body weight in the past 6 months
Exclusion Criteria:
1. Have unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity;
2. Be taking chronic aspirin or other non steroidal anti-inflammatory agents, or other medications known to be gastric irritants, and unwillingness to discontinue the use of these concomitant medications, antiarrythmics, anti-anginal medications, anticoagulants or medications for congestive heart failure;
3. Be taking blood pressure medications, unless their blood pressure is controlled and they have been at stable dose for at least 3 months;
4. Have type 1 diabetes or type 2 diabetes requiring oral medications or insulin;
5. History or symptoms of thyroid disease which is not controlled by medication;
6. Have severe renal, hepatic, pulmonary disease or cancer;
7. Past history of gastrointestinal surgery (excluding uncomplicated appendectomy);
8. Have a history of adhesive peritonitis;
9. History or symptoms of esophageal and/or gastric varices;
10. Have history or congenital or acquired GI anomalies (e.g. atresias, stricture, and /or diverticula);
11. History or symptoms of inflammatory bowel disease, such as Chron's disease;
12. History of/ signs and /or symptoms of duodenal or gastric ulcer;
13. Have gastroparesis;
14. Pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential);
15. Currently using pharmaceutical agents for weight loss;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
64 Years
Study:
NCT01288456
Study Brief:
Protocol Section:
NCT01288456