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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT05140694
Eligibility Criteria:
Inclusion Criteria:
1. age 20 or over
2. uncontrolled HbA1c (7\~10%) with metformin and/or sulfonylurea
3. Hepatic steatosis estimated by Fibroscan (CAP ≥258 dB/m)
4. MAFLD: presence of any conditions
1. Overweight or obese: BMI ≥23 kg/m2 (Asian)
2. Metabolic dysregulation: at least of two of following criteria
* Waist circumference: ≥90/80 cm in men and women (Asian)
* Blood pressure ≥130/85 mmHg or drug treatment
* Plasma triglycerides ≥150 mg/dL or drug treatment
* Plasma HDL-cholesterol \<40/50 mg/dL for men and women or drug treatment
* Prediabetes (i.e. fasting glucose levels 100 to 125 mg/dL or 2-hour post-load glucose levels 140 to 199 mg/dL or HbA1c 5.7% to 6.4%
* HOMA-insulin resistance score ≥2.5
* Plasma high-sensitivity CRP \>2 mg/L
Exclusion Criteria:
1. Significant alcohol consumption
2. Other competing causes for hepatic steatosis: viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha1 anti-trypsin deficiency, Celiac disease, Overt hypothyroidism, other secondary causes
3. Type 1 diabetes mellitus
4. medication usage within 3 months: vitamin E, PUFA, UDCA, fish oil, SGLT2 inhibitors, GLP1-RAs, TZDs
5. Severe organ dysfunction
1. liver damage: AST/ALT \>x5 UNL, albumin \<3.2, platelet \<60k, Child-Pugh-Turcotte stage B or C
2. kidney damage: serum creatinine ≥2.0 mg/dL or eGFR \<50 mL/min/1.72m2
6. Hepatocellular carcinoma, active tumor, or metastasis
7. End-stage liver disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
90 Years
Study:
NCT05140694
Study Brief:
Protocol Section:
NCT05140694