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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Liver Diseases; Weight Loss; NAFLD
• Intervention / Treatment: Behavioral: YMCA class

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: YMCA Class; 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.

Behavioral: YMCA class; The Gastroenterologists of Weill Cornell Medical College that are associated with this trial want to implement the YMCA's DPP in the NAFLD population as a structured lifestyle modification/educational intervention. The hypothesis is that the NAFLD patients who complete the YMCA's DPP will also have weight loss and improvement in hepatic steatosis. Importantly, positive results in this New York City-based pilot study would provide a strong rationale for determining whether such a program could be useful to treat NAFLD at established YMCA DPP sites across the country.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of the YMCA's Diabetes Prevention Program on NAFLD	Determine the effect of the YMCA's Diabetes Prevention Program on NAFLD as determined by comparison of liver enzymes pre- and post- program - we'll look at the changes of ALT levels to determine the aforementioned. We will perform these diagnostic tests in order to determine the effectiveness of the 16 weeks of sessions.	104 weeks from the start of the study
Determine if Liver Fat via Fibroscan Controlled Attentuation Pattern score has decreased as a result of YMCA program	Evaluate the amount of liver fat as determined by Fibroscan Controlled Attenuation Pattern (CAP) score in patients with NAFLD pre- and post- participation in the diabetes prevention program with the YMCA. The CAP range should be 100-400, without any sub-scales reported. Lower values in the range represent less 'fat', making it a better score.	104 weeks from the start of the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring the effectiveness of the YMCA Program, as per SF-36 patient-reported questionnaires	Determine the effect of YMCA's DPP on quality of life in patients with NAFLD as per SF-36 questionnaire.	104 weeks from the start of the study
Measuring the effectiveness of the YMCA Program, as per each patient's BMI	Determine the effect of YMCA's DPP on BMI in patients with NAFLD. We are reporting this as an aggregate of Body Mass Index.	104 weeks from the start of the study
Measuring the effectiveness of the YMCA Program, as per the DEXA scan	Determine the effect of YMCA's DPP on body composition (aggregated via body fat percentage and lean and fat body mass) using dual-energy X-ray absorptiometry (DEXA).	104 weeks from the start of the study
Measuring the effectiveness of the YMCA Program, as per metabolic blood work that's analyzed	Determine the effect of YMCA's DPP on levels of systemic factors linked to the metabolic syndrome. The metabolites that will be studied are all research-related blood work.	104 weeks from the start of the study

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: YMCA
• Investigators: Principal Investigator: Sonal Kumar, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2018
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: April 18, 2018
• First Posted (Actual): April 30, 2018

Study Record Updates

• Last Update Posted (Actual): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 26, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Body Weight; Body Weight Changes; Liver Diseases; Fatty Liver; Weight Loss; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 1709018542

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No