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 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
NCT ID:
NCT00999050
Eligibility Criteria:
Inclusion Criteria:
Adult males and females who meet the following inclusion criteria will be offered the opportunity to participate in the study:
1. Diagnosis of type 2 Diabetes Mellitus (T2DM) confirmed by the following criteria:
1. normal or high C-peptide level (\> 0.9 ng/ml) to exclude type 1 Diabetes Mellitus
2. positive glucagon test to confirm T2DM
3. fasting plasma glucose of 126 mg/dl or more on at least two occasions
2. Body mass index (BMI) 26 kg/m2 or greater, and less than 35 kg/m2
3. History of T2DM for not longer than 8 years, as long-standing disease beyond 8 years correlates with failure to achieve diabetes resolution after gastric bypass
4. No contraindication for surgery or general anesthesia as determined by a multidisciplinary bariatric surgery team (surgeon, anesthesiologist, internist, dietitian, psychologist)
5. Between 18 and 65 year of age
6. Able to provide informed consent
7. If a female with reproductive potential, she has to agree to use a reliable method of birth control for at least one year from the date of surgery
Exclusion Criteria
Subjects who meet any of the following exclusion criteria will not be eligible to participate in the study:
1. Enrollment in another clinical study, which involves an investigational drug
2. Diagnosis of type 1 Diabetes Mellitus or other genetic forms of Diabetes Mellitus
3. Significant renal failure of chronic liver disease (except NAFLD)
4. Major psychological disorders
5. Pregnancy - all female subjects will have serum beta-hCG prior to operation, and must use birth control of their choice to avoid pregnancy during the first year after surgery
6. Previous gastric or esophageal surgery
7. Immunosuppressive drugs including corticosteroids
8. Coagulopathy defined as an INR \> 1.5 or platelet count \< 50,000/µl
9. Anemia defined as a Hb \<10.0 g/dl
10. Inflammatory bowel diseases or other medical condition that would serve as a contraindication to gastric bypass (eg. celiac sprue, pancreatic insufficiency)
11. A severe concurrent illness that is likely to limit life or require extensive systemic treatment (e.g. cancer)
12. A pre-existing major complication of diabetes:
1. unstable, proliferative retinopathy
2. severe autonomic cardiac neuropathy or intestinal neuropathy
3. Myocardial infarction within the previous year, current unstable angina, or poorly-controlled congestive heart failure (Stage III)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00999050
Study Brief:
Protocol Section:
NCT00999050