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:
NCT01516320
Eligibility Criteria:
Inclusion Criteria: Post GBP, LAGB or VSG Subjects
* Must be able to attend 4 study visits at St. Luke's Roosevelt Hospital Center in Manhattan, New York City
* History of Type 2 Diabetes before surgery
Inclusion Criteria:
* 35 \< BMI \< 50
* Non-Smoker
* Total Body Weight \< 300 LBS
* 30\<Age\<60
* HbA1c \< 9%
* Resting Blood Pressure \< 160/100 mmHg
* Beta Blockers discontinued 2 weeks prior
* Fasting Triglyceride Concentration \< 600 mg/dl (patient can be on dyslipidemia medications)
* Without recent (within last 6 months) CHD history (prior history of angioplasty or coronary artery bypass surgery with normal stress test ok)
Exclusion Criteria:
1. Patients with abnormal thyroid, renal function, known malabsorption syndrome or a seizure disorder requiring anti epileptic therapy, and/or elevation of liver enzymes three times above the normal limit.
2. Patients should not have significant secondary complications from diabetes that would preclude undergoing gastric by-pass surgery. This would include significant psychiatric, renal or neurological, or known active coronary artery disease.
3. Any abnormality during the maximum exercise stress test that indicates it would be unsafe to undergo bariatric surgery.
4. Currently pregnant or nursing.
5. Known cardiovascular disease
6. Patient with current mucosal (gastrointestinal, respiratory, urogenital) or skin (cellulitis) infection
7. HbA1c \>9% and diabetes diagnosed more than 6 years prior to enrollment, or patients taking insulin or TZD (Avandia, Actos, Exenatide, DPP-IV inhibitors etc.) at the time of enrollment.
8. Patients diagnosed with intestinal conditions such as chronic diarrhea, diverticulitis, or irritable bowel syndrome. These clinical conditions would interfere with the collection and interpretation of the H2 breath test.
9. Any other condition which, in the opinion of the investigators, may make the candidate unsuitable for participation in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01516320
Study Brief:
Protocol Section:
NCT01516320