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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT05196867
Eligibility Criteria:
Inclusion Criteria:
1\. Evidence of steatosis (CAP score ≥ 290 by vibration controlled transient elastography) OR Evidence of liver fibrosis (FIB-4 index ≥ 1.6 or fibrosis grade ≥ F2 by vibration controlled transient elastography \[F2 score ≥ 8kPa\]) AND meets one of the following criteria: i. overweight or obese (BMI≥23 in Asians or BMI≥25 in other racial groups), OR ii. presence of type II diabetes mellitus, OR iii. lean/normal weight with presence of at least two metabolic risk abnormalities, OR:
1. Waist circumference ≥90/80 cm in Asians or ≥102/88 cm in other racial groups)
2. Blood pressure ≥130/85 mmHg or specific drug treatment
3. Plasma triglycerides ≥150 mg/dl or specific drug treatment
4. Plasma HDL-cholesterol \<40 mg/dl for men and \<50 mg/dl for women, or specific drug treatment
5. Prediabetes (fasting glucose levels 100-125 mg/dl , or HbA1c 5.7-6.4% ) iv. AUDIT-C ≥4 for men and ≥3 for women AND AUDIT-10 = 8-15
AND/OR 2. Evidence of liver fibrosis (FIB-4 index ≥ 1.6 or fibrosis grade ≥ F2 by vibration controlled transient elastography) and presence of one of the following:
1. chronic HBV (HBsAg+ or taking anti-HBV therapy), or
2. chronic HCV (1. detectable HCV RNA \> 4 months or a 2. history of HCV infection and taking anti-HCV therapy)
3\. At least 18 years old 4. Speak and read English or Spanish 5. Access to smartphone with data plan or Wi-Fi access 6. Willing to receive up to 12 text messages per week
Exclusion Criteria:
1. Pregnant or planning to become pregnant in next 12 months (by self-report)
2. Medical contraindications to home-based exercise or low-fat, high-vegetable-and-fruit diet
3. Recent or planned surgery that would interfere with home-based exercise or a low-fat, high vegetable and fruit diet
4. Current or prior history of primary liver cancer or cancer that is metastatic to the liver
5. AUDIT-10 score \>15
6. Family or household member already enrolled into study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05196867
Study Brief:
Protocol Section:
NCT05196867