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 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
NCT ID:
NCT01047735
Eligibility Criteria:
Inclusion Criteria:
* Age 25 to 55 years
* Mild to moderate obesity with a BMI between 30 and 40 kg/m2
* For potential subjects with BMI 35 to 40 kg/m2: T2DM confirmed by either a documented fasting blood glucose \> 126 mg/dl OR treatment with an anti-diabetic medication
* For potential subjects with BMI 30 to 35 kg/m2: T2DM that is difficult to control medically and is recommended for the study by the subject's endocrinologist AND treatment with an anti-diabetic medication
* Willingness to be randomized to a surgical intervention
Exclusion Criteria:
* Prior bariatric or foregut surgery
* Poor overall general health
* Impaired mental status
* Drug and/or alcohol addiction
* Current smoking
* Pregnant or plans to become pregnant
* Type 1 Diabetes Mellitus
* Portal hypertension and/or Cirrhosis
* Failed study-related nutrition or psychological assessment
* Current participation in any other research study
* Inability to provide informed consent
* Unlikely to comply with study protocol
* Unable to communicate with study staff
* Unable to exercise (walk a city block or a flight of stairs)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
55 Years
Study:
NCT01047735
Study Brief:
Protocol Section:
NCT01047735