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 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT04004403
Eligibility Criteria:
INCLUSION CRITERIA:
* Age between 18 to 65 years old
* BMI between 30.0 and 59.9 kg/m2
* NAFLD (hepatic steatosis ≥ 5% confirmed by MRI-PDFF)
* Sedentary (\<20 min, 2x/week of light activity at 3-4 metabolic equivalents (METs) for 3 mo prior to study)
EXCLUSION CRITERIA:
* Have chronic liver disease other than NAFLD (hepatitis B or C, primary biliary cirrhosis, sclerosing cholangitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, α1-antitrypsin deficiency)
* Consume excessive amounts of alcohol women: 70 g of ethanol (5 alcoholic drinks per week) and men 140 g of ethanol (10 drinks per week) in the past 6 months)
* Have a history of known cardiovascular, pulmonary or renal disease
* Diagnosed T1DM or T2DM
* Are not weight stable for 3 months prior to the beginning of study (weight gain or loss \> 4 kg)
* Are claustrophobic or have implanted metallic/electrical devices (e.g. cardiac pacemaker, neuro-stimulator)
* Are taking drugs that induce steatosis (e.g. corticosteroids, estrogens, methotrexate, Ca channel blockers)
* Are taking drugs that benefit NAFLD (e.g. betaine, pioglitazone, rosiglitazone, metformin, or gemifibrozil)
* Are taking drugs that influence study outcomes (weight loss medications)
* Are perimenopausal or have an irregular menstrual cycle (menses that does not appear every 27-32 days)
* Are pregnant, or trying to become pregnant
* Are smokers
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04004403
Study Brief:
Protocol Section:
NCT04004403