YMCA Diabetes Prevention Program for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD)

Description

This study is for men and women have been diagnosed with non-alcoholic fatty liver disease (NAFLD) and will consequently participate in the YMCA's Diabetes Prevention Program.

Study Start Date

January, 03 2018

Estimated Completion Date

September 2021

Interventions

  • Behavioral: YMCA class

Study ID

Weill Medical College of Cornell University -- 1709018542

Status

Recruiting

Trial ID

NCT03512184

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

40

Sponsor

Weill Medical College of Cornell University

Inclusion Criteria

    1. Age ?18 2. Must provide signed written informed consent and agree to comply with the study protocol 3. BMI >25 kg/m² 4. Hepatic steatosis by imaging or histology 5. Baseline Fibroscan CAP score > 238 dB/m 6. ALT >19IU/mL in females, ALT >30IU/mL in males

Exclusion Criteria

    1. Unclear etiology of liver disease 2. Competing etiologies for hepatic steatosis 3. Co-existing causes of chronic liver disease according to standard diagnostic testing including, but not restricted to:
  • Positive hepatitis B surface antigen
  • Positive hepatitis C virus RNA
  • Suspicion of drug-induced liver disease
  • Alcoholic liver disease
  • Autoimmune hepatitis
  • Wilson's disease
  • Hemochromatosis
  • Primary biliary cholangitis or primary sclerosing cholangitis 4. Known or suspected hepatocellular carcinoma 5. Current or recent history (<5 years) of significant alcohol consumption. For men, significant consumption is defined as >30g of alcohol per day. For women, it is defined as >20g of alcohol per day. 6. Compensated and decompensated cirrhosis (clinical and/or histologic evidence of cirrhosis). NASH patients with fibrosis stage = 4 according to the NASH CRN fibrosis staging system are excluded. 7. Pregnant females 8. Mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain 9. Inability to perform Fibroscan and/or invalid study

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Weill Cornell Medical College - New York, New York 50.7 miles Marlene FeronRigodon RN 646-962-2085 maf2062@med.cornell.edu

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