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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT03125369
Eligibility Criteria:
Inclusion Criteria:
* aged between 20 to 65 years
* at least 2 years of T2DM
* a BMI between 28 to 42 kg/m2
* a HbA1c level above 7% despite multiple oral medications (\> 2) at higher than or equal to half-maximal dose, or already using insulin injection for more than 6 months
* no active cardiovascular diseases, and
* a ASA grade II or below
* a fasting C-peptide \< 0.6ug/L
Exclusion Criteria:
* significant anaesthetic risk ASA grade III or above
* history of diabetic ketoacidosis
* uncontrolled DM with HbA1c \> 12%
* malignancy diagnosed within 5 years
* chronic renal failure requiring dialysis
* previous upper abdominal surgery affecting gastroduodenal configuration
* major psychiatric illness including major depression and substance abuse
* pregnancy or ongoing breast-feeding
* inmates
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT03125369
Study Brief:
Protocol Section:
NCT03125369