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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT00975533
Eligibility Criteria:
Inclusion Criteria:
* Able to provide written informed consent
* Adult patients aged between 18 and 60 years (inclusive)
* Male or female of Chinese ethnicity
* Type 2 diabetes mellitus with disease duration of greater than 2 and less than 10 years
* severe obesity, includes BMI 25 to 27.5 kg/m and central obesity defined by waist circumference greater than 90 cm in women and greater than 95 in men, or BMI greater than 27.5 to less than 35 kg/m
* HbA1c greater than or equals to 7.5% but less than 10% despite treated with maximum dose or maximally tolerated dose of 2 anti-diabetic drugs (OAD) with good drug compliance
Exclusion Criteria:
* On anti-obesity drugs
* On insulin treatment at the time of the recruitment
* On glitazone or incretins (dipeptidyl peptidase-4 inhibitor or glucagons-like peptide-1) treatment
* On any implantable device including cardiac pacing
* Anticipated to have MRI examinations
* Fasting C-peptide level less than 0.5g/L
* Renal impairment (defined as serum creatinine greater than 150mol/L and/or estimated glomerular filtration rate less than 60 mL/min/1.73m)
* Significant liver impairment (ALT more than 3 times upper limit of normal range)
* Active malignant disease. Patients with malignant disease who have been disease-free for at least 5 years are eligible
* Active infection
* Active and uncontrolled thyroid diseases
* Childbearing age female patients without reliable contraceptive methods
* Life expectancy less than 12 months
* Administration of another investigational drugs or procedures within 4 weeks before screening
* Any medical illness or condition as judged by the investigators as ineligible to participate the study
* Special population, e.g. prisoner, mentally disabled, investigators' student or employees
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00975533
Study Brief:
Protocol Section:
NCT00975533