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 @ 5:22 PM
Ignite Modification Date:
2025-12-24 @ 5:22 PM
NCT ID:
NCT05346250
Eligibility Criteria:
Inclusion criteria
1. Subjects with NAFLD determined by 1H MRS (intrahepatic triglyceride content ≥5%);
2. 40-65 years old;
3. Waist circumference \>90cm for men and \>85cm for women
Exclusion criteria
1. Consumed more than an average of 140 grams of ethanol (10 alcoholic drinks) per week in men and 70 grams of ethanol (five drinks) in women during the past six months;
2. A history of acute or chronic viral hepatitis, drug-induced liver diseases, and autoimmune hepatitis;
3. Myocardial infarction in the past six months;
4. Biliary obstructive diseases;
5. Uncontrolled hypertension (i.e. systolic BP\>180 mmHg, and/or diastolic DBP \>100 mmHg);
6. Chronic kidney disease (serum creatinine ≥1.5 mg/dL in men and ≥1.3 mg/dL in women);
7. Heart failure (New York Heart Association III or IV);
8. Currently participating in weight loss programs;
9. Currently pregnant or planning to be pregnant;
10. Having any medical condition that would affect metabolism (i.e. diabetes, known hyperthyroidism or hypothyroidism);
11. Having a medical condition that would limit exercise participation and taking medication that would affect metabolism or weight loss (i.e. thyroid medication and glucocorticoids) or would alter the heart rate response during exercise (i.e. β-blockers);
12. Unable to participate in the follow-up examination.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT05346250
Study Brief:
Protocol Section:
NCT05346250