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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT03480594
Eligibility Criteria:
Inclusion Criteria:
* Ages 18 to 99 years.
* All races, ethnicities and gender identification may be included. Subjects must meet all of the inclusion and exclusion criteria to be included in the study.
* Either fatty liver diagnosis (defined as \>5.6% fat content in the liver) or healthy control
* While all races and ethnicities will be included, subjects must be able to read and speak the English language. Once the protocol is established, Spanish-speaking participants will be included.
* Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Exclusion Criteria:
Fatty Liver Subjects
* No subjects taking hypoglycemic agents or insulin will be enrolled. There is no exclusion based on fasting glucose.
* Subjects with major mental health conditions such as schizophrenia and bipolar disorder that would limit compliance with study requirements will not participate. In general, subjects with any form of medical instability such as seizure disorders, significant COPD, significant asthma, left ventricular dysfunction will not participate.
* Medications for control of hypercholesterolemia, hypertriglyceridemia or hyperglycemia.
Healthy Control Subjects
* Liver disease or other chronic illness
* Diagnosis of type I or type II diabetes
* No subjects taking hypoglycemic agents or insulin will be enrolled. There is no exclusion based on fasting glucose.
* A potential subject with any major medical, surgical or psychiatric condition will not participate. These conditions include but are not limited to thyroid disease, chronic metabolic illness, known vascular disease, current cancer diagnosis and/or treatment.
* Subjects with major mental health conditions such as schizophrenia and bipolar disorder that would limit compliance with study requirements will not participate. In general, subjects with any form of medical instability such as seizure disorders, significant COPD, significant asthma, left ventricular dysfunction will not participate.
* Medications for control of hypercholesterolemia, hypertriglyceridemia or hyperglycemia.
All Subjects
* No prior hepato-biliary surgery.
* Donated blood within the prior 4 weeks.
* Consume more than 10 grams of ethanol per day.
* Cirrhosis or any form of viral hepatitis.
* Prior documented hepatic reaction to drugs with a known hepatotoxicity profile such as isoniazid, methotrexate, phenytoin, propylthiouracil, valproate, etc.
* Pregnant/Lactating
* Receiving any other investigational agents.
* Any contraindication noted on the UTSWMC MRI Screening Form including implants contraindicated at 3T, pacemakers, Implantable Cardioverter Defibrillators (ICD), etc., and significant claustrophobia.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT03480594
Study Brief:
Protocol Section:
NCT03480594