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

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03512184
Collaborator
YMCA (Other)
47
Enrollment
1
Location
1
Arm
59.9
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: YMCA class
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
47 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
The YMCA's Diabetes Prevention Program (YMCA's DPP) for the Treatment of Nonalcoholic Fatty Liver Disease
Actual Study Start Date :
Jan 3, 2018
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. Known or suspected hepatocellular carcinoma

  2. 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.

  3. 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.

  4. Pregnant females

  5. Mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain

  6. Inability to perform Fibroscan and/or invalid study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Weill Cornell Medical College New York New York United States 10065

Sponsors and Collaborators

  • Weill Medical College of Cornell University
  • YMCA

Investigators

  • Principal Investigator: Sonal Kumar, MD, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT03512184
Other Study ID Numbers:
  • 1709018542
First Posted:
Apr 30, 2018
Last Update Posted:
Jan 27, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Weight Loss

Study Results

No Results Posted as of Jan 27, 2022