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 @ 3:30 PM
Ignite Modification Date:
2025-12-24 @ 3:30 PM
NCT ID:
NCT02690792
Eligibility Criteria:
Inclusion Criteria:
NAFLD/NASH SUBJECTS
* Male and Female, Age 18-65 years of all racial and ethnic origins
* Hepatic steatosis by radiologic study with or without liver enzyme elevation
* BMI \< 35 kg/m2
* English or Spanish language
* Females of childbearing potential must be willing to practice an acceptable form of birth control throughout the protocol
* May also have Type 2 Diabetes (T2DM) with:
Hemoglobin A1C \< 8.5 % of total Prior, current or no oral antidiabetic medication usage
CONTROL SUBJECTS:
* Age 18-65 years.
* BMI ≤ 35 kg/m2
* English or Spanish language
* Females of childbearing potential must be willing to practice an acceptable form of birth control throughout the protocol
* May also have T2DM with:
Hemoglobin A1C \< 8.5 % of total Prior, current or no oral antidiabetic medication usage
Exclusion Criteria:
ALL SUBJECTS:
* Diabetes type 1
* Diabetes type 2 with:
Hemoglobin A1C \< 8.5 % of total Current or prior insulin usage
* Medications or conditions that confound the diagnosis of NAFLD
* Excessive alcohol intake (\>30 g/day in men and \>20 g/day in women)
* Chronic liver disease other than NAFLD/NASH
* Glucocorticoids
* Medications or conditions that alter hepatic metabolism
* Autoimmune disorders
* Current or chronic infection
* Other endocrine disorders
* Recent weight loss (\> 10 lbs. within the past 3 months)
* Prescription weight-loss medications
* Medical conditions likely to increase the risk of intervention Renal insufficiency (creatinine \> 1.4 mg/dL) Baseline metabolic acidosis Congestive heart failure
* Conditions or behaviors likely to affect the conduct of the study Pregnancy and breastfeeding confirmed by urine pregnancy test prior to all imaging or invasive procedure such as the euglycemic clamp, stable isotope studies, as well as prior to initiation of Vitamin E.
* Concurrent participation in another research project
* Inability to accept treatment assignment
* Major psychiatric disorder or substance abuse
CONTROL SUBJECTS (in addition to the above):
* Liver disease Elevated liver function tests Hepatic steatosis
* Metabolic syndrome Hypertriglyceridemia (fasting plasma triglycerides \> 150 mg/dL). Systolic blood pressure \> 140 mmHg Diastolic blood pressure \> 80 mmHg
* Exercise above activities of daily living
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02690792
Study Brief:
Protocol Section:
NCT02690792