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 @ 12:08 PM
Ignite Modification Date:
2025-12-24 @ 12:08 PM
NCT ID:
NCT03821961
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes or prediabetes
* Body mass index \>25.0 kg/m2
* Written informed consent
Exclusion Criteria:
* Diabetes induced by chronic pancreatitis or pancreas cancer
* Chronic glucocorticoid usage
* Significant coronary artery disease or cerebrovascular disease within the previous 3 months
* Uncompensated congestive heart failure
* Severe pulmonary disease defined as FEV1 \< 50% of predicted value
* End stage renal disease on dialysis
* Acute infectious disease within the previous 3 months
* Pulmonary thromboembolism or thrombophlebitis within the previous 3 months
* History of cancer (except for basal cell skin cancer or cancer in situ)
* Prior gastrointestinal surgery (except for appendectomy or hemorrhoidectomy)
* Gastrointestinal disorders, malabsorptive disorders, or inflammatory bowel disease
* History of chronic liver disease (except for NAFLD/NASH)
* Psychiatric disorders including dementia, active psychosis, severe depression requiring \> 2 medications, history of suicide attempts, alcohol or drug abuse within the previous 5 years
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT03821961
Study Brief:
Protocol Section:
NCT03821961