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

Weill Cornell Medicine (WCM)

Status: Completed

Conditions: Weight Loss; NAFLD; Liver Diseases

Treatments: Behavioral: YMCA class

Study type: Interventional

Funder types: Other

Identifiers

NCT03512184

1709018542

Details and patient eligibility

About

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.

Full description

This study is for men and women who participate in the YMCA's Diabetes Prevention Program (YMCA's DPP) and have been diagnosed with non-alcoholic fatty liver disease (NAFLD). There will be no administration of study drug. The purpose of this study is to see if participation in the YMCA's DPP will result in weight loss and improvement in the liver in patients with fatty liver disease.

Eligible participants will visit Weill Cornell Medical College's Gastroenterology and Hepatology clinic to review their medical history, physical examination, complete a survey, and conduct imaging tests (FibroScan, ultrasound, DEXA scan) for their baseline visit. Blood will be collected as part of standard practice. An additional blood sample will be collected for storage. Subjects will complete 9 out of 16 weekly sessions. The YMCA's program will be conducted at Weill Cornell Medical College Gastroenterology and Hepatology Division.

Participants will be in the YMCA program for about 1 year and an additional 1 year in the long-term follow-up for data collection.

Participants will be compensated for their time.

Key eligibility criteria:

1. Men and women over 18 years of age.
2. Diagnosed with Non-alcoholic Fatty liver disease.
3. Detailed eligibility reviewed when contacting the study team.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

YMCA Class

Other group

Description:

This Arm's objective is to determine the effect of the YMCA's Diabetes Prevention Program on NAFLD as determined by comparison of liver enzymes pre- and post- program.

Treatment:

Behavioral: YMCA class