Characterization of Patients Referred to Indiana University for Evaluation and Management of Suspected Nonalcoholic Fatty Liver Disease
N
Niharika Samala, MD
Primary Investigator
Overview
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.
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
You may be eligible for this study if you meet the following criteria:
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Conditions:
Nonalcoholic Fatty Liver Disease, NAFLD
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Age: Between 18 Years - 100 Years
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Gender: All
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
Updated on
19 Apr 2024.
Study ID: 1702241508
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