Global Longitudinal Assessment of Nonalcoholic Fatty Liver Disease (NAFLD) using Magnetic Resonance Elastography (GOLD-MINE)
R
Raj Vuppalanchi, MD
Primary Investigator
Enrolling By Invitation
18-100 years
All
Phase
N/A
50 participants needed
2 Locations
Overview
NAFLD is a common liver disease in the United States. The causes of NAFLD are unknown, but are probably due to different reasons, from inherited characteristics to personal lifestyle. Some reasons may increase the chance of developing NAFLD (these are called “risk factors”) while other reasons may decrease the chance of developing NAFLD (“protective factors”). The factors that determine whether a patient progresses from NAFLD to more severe liver disease are unknown. The purpose of the GOLD-MINE study is to better understand nonalcoholic fatty liver disease (NAFLD) by yearly following and evaluating people with biopsy proven or a clinical diagnosis of NAFLD.
Description
Who is Eligible:
Inclusion criteria:
- Age at least 18 years at time of initial screening
- Written informed consent to participate
- Willingness to be followed for up to a minimum of 4 years
- Ability and willingness to give written, informed consent to be screened for and, if eligible, to be enrolled into the NAFLD longitudinal study
- Minimal or no alcohol use history consistent with NAFLD (see exclusion criteria)
- Participant may either have a clinical diagnosis of NAFLD-cirrhosis or have undergone a liver biopsy within 180 days of enrollment as part of standard of care.
- Collection of biosamples (serum, plasma, urine, DNA, and, if available, liver tissue) within 180 days of enrollment
- Patients with either biopsy-proven NAFLD, or patients with suspected NAFLD who are anticipating a liver biopsy, or patients with imaging evidence of cirrhosis who have either NAFLD-cirrhosis or cryptogenic cirrhosis by clinical criteria.
Exclusion criteria:
- Clinical or histological evidence of alcoholic liver disease:
- Participant with biopsy-proven NAFLD without cirrhosis: regular and excessive use of alcohol within the 2 years prior to interview defined as alcohol intake > 14 standard drinks on average per week for men and > 7 standard drinks on average per week for women.1, 2
- Participant with NASH-cirrhosis: any current alcohol consumption
- Total parenteral nutrition for more than 1 month within a 6-month period before baseline liver biopsy.
- Short bowel syndrome.
- History of gastric or jejunoileal bypass preceding the diagnosis of NAFLD. Bariatric surgery performed following enrollment is not exclusionary. Liver biopsies obtained during bariatric surgery cannot be used for enrollment because of the associated surgical or anesthetic acute changes and the weight loss efforts that precede bariatric surgery.
- History of biliopancreatic diversion.
- Evidence of chronic hepatitis B as marked by the presence of HBsAg in serum (participants with isolated antibody to hepatitis B core antigen, anti-HBc total, are not excluded)
- Evidence of chronic hepatitis C as marked by the presence of anti-HCV or HCV RNA in serum
- Low alpha-1-antitrypsin level and ZZ phenotype (both determined at the discretion of the investigator)
- Wilson's disease
- Known glycogen storage disease
- Known dysbetalipoproteinemia
- Known phenotypic hemochromatosis (HII greater than 1.9 or removal of more than 4 g of iron by phlebotomy)
- Prominent bile duct injury (florid duct lesions or periductal sclerosis) or bile duct paucity
- Chronic cholestasis
- Vascular lesions (vasculitis, cardiac sclerosis, acute or chronic Budd-Chiari, hepatoportal sclerosis, peliosis)
- Iron overload greater than 3+
- Zones of confluent necrosis, infarction, massive or sub-massive, pan-acinar necrosis
- Multiple epithelioid granulomas
- Congenital hepatic fibrosis
- Polycystic liver disease
- Other metabolic or congenital liver disease
- Evidence of systemic infectious disease
- Known HIV positive
- Disseminated or advanced malignancy
- Documented history of hepatocellular carcinoma
- Concomitant severe underlying systemic illness that in the opinion of the investigator would interfere with completion of follow-up
- Active drug use or dependence that, in the opinion of the study investigator, would interfere with adherence to study requirements
- Any other condition which, in the opinion of the investigator, would impede compliance or hinder completion of study
- Inability to provide informed consent
What is Involved:
GOLD-MINE is an observational study. This means that treatment for NAFLD, NASH, or NASH-related cirrhosis will not be provided by this study. The study will give information about NAFLD, NASH, or NASH-related cirrhosis and will not change your current treatment. There are no experimental treatments in this study.
This study includes one primary clinic visit and up to 10 additional annual visits with a minimum of 4 years follow-up requirement. If you do not agree to come back once a year for at least the next 4 years for the annual study visits, you cannot participate in this study.
Each visit will take about 2 hours of your time.
Compensation:
Participants are paid $50 for each completed visit and receive a parking pass.
Additional Information:
For questions about the study, contact the researcher, Dr. Raj Vuppalanchi at 317-278-1630.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Nonalcoholic Fatty Liver Disease,NAFLD,Fatty liver disease,Nonalcoholic steatohepatitis,NASH,cirrhosis
-
Age: Between 18 Years - 100 Years
-
Gender: All
Additional Information:
Updated on
15 May 2024.
Study ID: 14267
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