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 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT02041234
Eligibility Criteria:
Inclusion Criteria:
1. Established diagnosis of DM2 = or \< 10 years
2. Age 21-65
3. BMI 27-32.
4. HBA1c ≥ 8%, on maximum treatment from primary care physician
5. At least one of the following co-morbidities on treatment: hypertension, hyperlipidaemia, micro/macro-proteinuria or ≤class I nephropathy, retinopathy.
Exclusion Criteria:
1. Subjects who had previous Bariatric surgery or extensive upper abdominal surgery
2. Pregnant subjects.
3. Nephropathy requiring dialysis
4. Subjects who are not fit for general anaesthesia.
5. Subjects who are unsuitable for RYGB for whatever reason, medical/surgical/psychological.
6. Subjects who are unwilling or possibly unable to participate in the follow up process.
7. Subjects who are reluctant to be randomised into the two study groups.
8. Subjects who suffers from unstable psychiatric illness
9. Subjects who are active substance abusers
10. Glutamic acid decarboxylase antibody positive.
11. fasting C-peptide \< 300 pmol/L
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT02041234
Study Brief:
Protocol Section:
NCT02041234