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 @ 5:30 PM
Ignite Modification Date:
2025-12-24 @ 5:30 PM
NCT ID:
NCT05576168
Eligibility Criteria:
Inclusion Criteria:
1. Prior to conducting any trial-related activities, including those conducted to assess the subject's eligibility Informed consent of the subject;
2. Aged 18-60 years at the time of screening;
3. The diagnosis of diabetes was defined as fasting blood glucose above 7.0mmol/ L twice on different days on a normal diet
Exclusion Criteria:
1. HIV, hepatitis B or C ( self-reported ) or active pulmonary tuberculosis history :
2. history of malignant tumor ;
3. Severe liver dysfunction or kidney disease ( AST or ALT \> 3 times the normal upper limit, or eGFR \< 30ml min 1.73 m2 ) ;
4. History of severe cardiovascular and cerebrovascular diseases ( angina pectoris, myocardial infarction or stroke ) in the past 6 months :
5. history of severe gastrointestinal disease or gastrointestinal surgery in the past 12 months ;
6. There are other diseases that affect glucose and lipid metabolism : hyperthyroidism, hypothyroidism, cortex Hyperalcoholism, etc. ;
7. Secondary diseases or drugs lead to obesity, including : elevated cortisol ( such as Cushing 's syndrome ), sagging Obesity caused by body and hypothalamus injury, obesity caused by weight loss drug reduction / discontinuation, etc.
8. Drugs affecting body weight or energy intake / energy expenditure were used within 3 months before screening, including :
Sex steroids ( intravenous, oral or intra-articular ), tricyclic antidepressants, for psychiatric disorders
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05576168
Study Brief:
Protocol Section:
NCT05576168