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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03512184
• Other study ID #: 1709018542
• Status: Completed
• Phase: N/A
• Start date: January 3, 2018
• Est. completion date: September 12, 2021

Study information

• Verified date: January 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 12, 2021
• Est. primary completion date: September 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• NAFLD
• Non-alcoholic Fatty Liver Disease
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	YMCA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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