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

NCT03512184 | Completed

• 1 other identifier: 1709018542
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss; NAFLD; Liver Diseases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Measuring the effectiveness of the YMCA Program, as per SF-36 patient-reported questionnaires

  104 weeks from the start of the study

• Measuring the effectiveness of the YMCA Program, as per each patient's BMI

  104 weeks from the start of the study

• Measuring the effectiveness of the YMCA Program, as per the DEXA scan

  104 weeks from the start of the study

• Measuring the effectiveness of the YMCA Program, as per metabolic blood work that's analyzed

  104 weeks from the start of the study

Study Arms (1)

YMCA Class

OTHER

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

Interventions

YMCA class BEHAVIORAL

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.

YMCA Class

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unclear etiology of liver disease
• Competing etiologies for hepatic steatosis
• 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
• Known or suspected hepatocellular carcinoma
• 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.
• 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.
• Pregnant females

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• YMCA: collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Weight Loss; Non-alcoholic Fatty Liver Disease; Liver Diseases

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fatty Liver; Digestive System Diseases

Study Officials

• Sonal Kumar, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: April 30, 2018
• Study Start: January 3, 2018
• Primary Completion: September 12, 2020
• Study Completion: September 12, 2021
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

US (1)