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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT02488733
Eligibility Criteria:
Inclusion Criteria:
1. No contraindication for laparoscopic surgery or general anaesthesia.
2. Age ≥20 and ≤65 years.
3. BMI of between 30 and 42 kg/m2.
4. Documented new diagnosis of Type 2 Diabetes Mellitus obtained according to the following American Diabetes Association parameters: fasting blood glucose ≥ 126 mg/dl (7.0 mmol/l) and/or HbA1c ≥ 6.5% and no more than 8 months from enrollment in the study.
Exclusion Criteria:
1. Previous bariatric surgery or major abdominal surgery.
2. Patients with T2DM diagnosis treated with insulin.
3. Evidence of complications connected to diabetes at any stage (diabetic retinopathy, diabetic nephropathy/microalbuminuria, cardiovascular disease or neuropathy).
4. Cardiovascular diseases such as ischemia / coronary artery disease, arrhythmia, peripheral vascular diseases, congestive heart failure, history of heart attacks.
5. Kidney diseases including nephro-vascular hypertension, stenosis of the renal artery or chronic renal insufficiency.
6. Pregnancy
7. Diagnosis of psychiatric illness (including dementia, severe depression, history of suicide attempts) or abuse of alcohol or drugs in the previous 5 years.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT02488733
Study Brief:
Protocol Section:
NCT02488733