Clinical trial NCT03512184: YMCA Diabetes Prevention Program for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD)
Official title: The YMCA's Diabetes Prevention Program (YMCA's DPP) for the Treatment of Nonalcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
NAFLD
Liver Diseases
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: YMCA
First posted: 2018-04-30
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Effect of the YMCA's Diabetes Prevention Program on NAFLD
timeFrame: 104 weeks from the start of the study
measure: Determine if Liver Fat via Fibroscan Controlled Attentuation Pattern score has decreased as a result of YMCA program
timeFrame: 104 weeks from the start of the study
Secondary outcomes:
measure: Measuring the effectiveness of the YMCA Program, as per SF-36 patient-reported questionnaires
timeFrame: 104 weeks from the start of the study
measure: Measuring the effectiveness of the YMCA Program, as per each patient's BMI
timeFrame: 104 weeks from the start of the study
measure: Measuring the effectiveness of the YMCA Program, as per the DEXA scan
timeFrame: 104 weeks from the start of the study
measure: Measuring the effectiveness of the YMCA Program, as per metabolic blood work that's analyzed
timeFrame: 104 weeks from the start of the study
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Sonal Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References: