Weight LossNCT03512184
YMCA Diabetes Prevention Program for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD)
A study testing YMCA class in people with Weight Loss and NAFLD, run by Weill Medical College of Cornell University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Loss, NAFLD, Liver Diseases
- What is being tested?
- YMCA class
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2018to 12 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
Official title: The YMCA's Diabetes Prevention Program (YMCA's DPP) for the Treatment of Nonalcoholic Fatty Liver Disease
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.
Read the 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.
- Conditions
- Weight Loss, NAFLD, Liver Diseases
- Being tested
- YMCA class
- Medical subject headings
- Weight Loss, Non-alcoholic Fatty Liver Disease, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YMCA classBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: YMCA class |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Determine the effect of YMCA's DPP on quality of life in patients with NAFLD as per SF-36 questionnaire.
Measured: 104 weeks from the start of the study
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.
Measured: 104 weeks from the start of the study
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).
Measured: 104 weeks from the start of the study
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.
Measured: 104 weeks from the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start3 Jan 2018
- Primary completion12 Sep 2020
- Study completion12 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- YMCA
- Responsible party
- Sponsor
- Investigators
- Sonal Kumar, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512184
- Sponsor's protocol ID
- 1709018542
- Status last verified
- Jan 2023
- First submitted
- 6 Feb 2018
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The YMCA's Diabetes Prevention Program (YMCA's DPP) for the Treatment of Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT03512184
- Acronym / sponsor ID
- 1709018542
- Conditions
- Weight Loss, NAFLD, Liver Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- YMCA
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 12 Sep 2020 (actual)
- Study completion
- 12 Sep 2021 (actual)
- First posted
- 30 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YMCA Class | Other | Behavioral: YMCA classThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YMCA classThe 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. | Behavioural | YMCA Class |
Primary outcome
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.
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.
4 secondary outcomes
Measuring the effectiveness of the YMCA Program, as per SF-36 patient-reported questionnaires
Time frame: 104 weeks from the start of the study
Measuring the effectiveness of the YMCA Program, as per each patient's BMI
Time frame: 104 weeks from the start of the study
Measuring the effectiveness of the YMCA Program, as per the DEXA scan
Time frame: 104 weeks from the start of the study
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonal Kumar, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YMCA class in people with Weight Loss and NAFLD, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of the YMCA's Diabetes Prevention Program on NAFLD (time frame: 104 weeks from the start of the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.