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 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT04174768
Eligibility Criteria:
Inclusion Criteria:
* ≥20 years old
* body mass index ≥27.5 kg/m2, in case of type 2 diabetes
* body mass index ≥35 kg/m2, in case of non-type 2 diabetes
Exclusion Criteria:
* Prior complex gastrointestinal surgery, including that of the stomach, small intestine, large intestine, bile duct, pancreas, and spleen; Nissen, and trauma (except hemorrhoidectomy, herniorrhaphy, and appendectomy)
* Abdominal, thoracic, pelvic, and/or obstetric-gynecologic surgery within 3 months or at the discretion of the Investigator
* Cardiovascular conditions including significant known coronary artery disease (CAD), uncompensated congestive heart failure, history of stroke, or uncontrolled hypertension (defined as medially treated with the mean of three separate measurements systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg).
Subjects with CAD who were successfully treated with coronary artery bypass graft or percutaneous coronary intervention within 3 months and who have no evidence of active ischemia are eligible
* Kidney diseases including renovascular hypertension, renal artery stenosis, or end-stage renal disease
* Known history of chronic liver diseases including liver cirrhosis and alpha-1-antitrypsin deficiency
* Gastrointestinal disorders including a known history of celiac disease or any other malabsorptive disorders or inflammatory bowel disease (Crohn's disease or ulcerative colitis)
* Psychiatric disorders including dementia, active psychosis, history of suicide attempts, and alcohol or drug abuse within 12 months
* Severe pulmonary disease defined as forced expiratory volume at one second \<50% of the predicted value
* Anemia defined as hemoglobin \<8 in females and 10 in males
* Malignancy within 5 years (except squamous cell and basal cell cancer of the skin). Subjects diagnosed with early or stage 1 cancer that was successfully treated are eligible based on the Investigator's discretion
* Any condition or major illness that in the Investigator's judgement places the subject at undue risk by participating in the study
* Pregnancy
* Unable to understand the risks, realistic benefits, and compliance requirements of each program
* Use of investigational therapy or participation in any other clinical trial within 3 months
* Plans to move outside South Korea within the next 2 years
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT04174768
Study Brief:
Protocol Section:
NCT04174768