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



Status:Recruiting
Conditions:Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:2/24/2019
Start Date:January 3, 2018
End Date:September 30, 2021
Contact:Mallory Ianelli, RN
Email:mai2016@med.cornell.edu
Phone:646.962.4040

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The YMCA's Diabetes Prevention Program (YMCA's DPP) for the Treatment of Nonalcoholic Fatty Liver Disease

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.

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.

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
We found this trial at
1
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New York, New York 10021
Phone: 646-962-4040
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