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

Primary Purpose

Weight Loss, NAFLD, Liver Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
YMCA class
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Weight Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Weill Cornell Medical College

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

YMCA Class

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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).
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.

Full Information

First Posted
February 6, 2018
Last Updated
January 31, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
YMCA
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1. Study Identification

Unique Protocol Identification Number
NCT03512184
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 3, 2018 (Actual)
Primary Completion Date
September 12, 2020 (Actual)
Study Completion Date
September 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
YMCA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, NAFLD, Liver Diseases

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
YMCA Class
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
YMCA class
Intervention Description
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 Outcome Measure Information:
Title
Effect of the YMCA's Diabetes Prevention Program on NAFLD
Description
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.
Time Frame
104 weeks from the start of the study
Title
Determine if Liver Fat via Fibroscan Controlled Attentuation Pattern score has decreased as a result of YMCA program
Description
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.
Time Frame
104 weeks from the start of the study
Secondary Outcome Measure Information:
Title
Measuring the effectiveness of the YMCA Program, as per SF-36 patient-reported questionnaires
Description
Determine the effect of YMCA's DPP on quality of life in patients with NAFLD as per SF-36 questionnaire.
Time Frame
104 weeks from the start of the study
Title
Measuring the effectiveness of the YMCA Program, as per each patient's BMI
Description
Determine the effect of YMCA's DPP on BMI in patients with NAFLD. We are reporting this as an aggregate of Body Mass Index.
Time Frame
104 weeks from the start of the study
Title
Measuring the effectiveness of the YMCA Program, as per the DEXA scan
Description
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).
Time Frame
104 weeks from the start of the study
Title
Measuring the effectiveness of the YMCA Program, as per metabolic blood work that's analyzed
Description
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.
Time Frame
104 weeks from the start of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonal Kumar, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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