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Completed

NCT Number: NCT03512184

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

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.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Digestive System Diseases Fatty Liver Liver Diseases NAFLD Non-alcoholic Fatty Liver Disease Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medical College

New York, 10065, United States

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain
  • Inability to perform Fibroscan and/or invalid study

Treatment and study plan

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.

Primary outcomes

  1. Effect of the YMCA's Diabetes Prevention Program on NAFLD

    Time frame: 104 weeks from the start of the study

    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.

  2. Determine if Liver Fat via Fibroscan Controlled Attentuation Pattern score has decreased as a result of YMCA program

    Time frame: 104 weeks from the start of the study

    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.

Secondary outcomes

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

    Time frame: 104 weeks from the start of the study

    Determine the effect of YMCA's DPP on quality of life in patients with NAFLD as per SF-36 questionnaire.

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

    Time frame: 104 weeks from the start of the study

    Determine the effect of YMCA's DPP on BMI in patients with NAFLD. We are reporting this as an aggregate of Body Mass Index.

  3. Measuring the effectiveness of the YMCA Program, as per the DEXA scan

    Time frame: 104 weeks from the start of the study

    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).

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

    Time frame: 104 weeks from the start of the study

    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.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • YMCA

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Apr 30, 2018
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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