1702241508 1702241508 1702241508 Characterization of Patients Referred to Indiana University for Evaluation and Management of Suspected Nonalcoholic Fatty Liver Disease

NS

Niharika Samala, MD

Principal Investigator

Status: Enrolling By Invitation Ages: 18 Years - 100 Years Gender: All Genders Phase: N/A 3 Locations

Brief Description

What is this study about?
Patients with nonalcoholic fatty liver disease have varied etiologies, associated risk factors and disease severity.  One purpose of this study is to determine the possible etiological factors, risk factors, and disease severity of all patients referred to Digestive and Liver Diseases Clinics for presumed NAFLD.  Another purpose of the study is also to develop a database of people with fatty liver for future research projects.

Detailed Description

What happens during the study?
Participation will last for two study visits, with one study visit at the time of enrollment and one at some point at least one year after the first visit.  Study visits may last up to one hour. Study visits will include the following:
  • Complete questionnaires
  • Undergo a painless scan of your liver using transient elastography called a FibroScan®.  
  • Undergo bioelectrical impedance ( “In Body” machine will send safe, non-painful low-level currents throughout your body using hand and foot electrodes to analyze body fat and muscle content).
  • Provide blood and urine samples.

Eligibility of study

Inclusion criteria:

1.    Adults aged 18 years or older

2.    Able to read and understand English

3.    Ability to provide informed consent

Exclusion critieria:

1.    Fasting for less than three hours, as required for transient elastography

2.    Has current, significant alcohol consumption or history of significant alcohol consumption for a period of more than three consecutive months at any time within one year prior to screening.  Significant alcohol consumption is defined as more than 20 grams per day in females and more than 30 grams per day in males.  On average, a standard drink is considered to be 14 grams of alcohol

3. People with active substance abuse

4. Unable or unwilling to sign the informed consent statement and HIPAA Authorization form

5. Meets the criteria for prisoners or those under the care of the Department of Corrections

Interested in participating?

Enrollment in IU School of Medicine clinical trials is managed through our All IN for Health program. Many studies only accept people who are part of an invited group. Visit allinforhealth.info to connect with the study team, or contact your doctor to see if you are eligible.