Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-30 @ 2:17 AM
Study NCT ID:
NCT04988204
Status:
COMPLETED
Last Update Posted:
2021-08-03
First Post:
2021-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diabetes Prevention Program for the Treatment of Nonalcoholic Fatty Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-28', 'studyFirstSubmitDate': '2021-07-28', 'studyFirstSubmitQcDate': '2021-07-28', 'lastUpdatePostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants in the program at the end of the study', 'timeFrame': '12 months', 'description': 'Retention defined as number of patients in the program at the end of the study'}], 'secondaryOutcomes': [{'measure': 'Change in Weight', 'timeFrame': 'baseline and 12 months', 'description': 'Change in Weight at 12 months as compared to baseline'}, {'measure': 'Hepatic steatosis via Fibroscan', 'timeFrame': 'Baseline', 'description': 'Changes in hepatic steatosis measured with fibroscan using the controlled attenuated parameter.'}, {'measure': 'Hepatic steatosis via Fibroscan', 'timeFrame': '6 months', 'description': 'Changes in hepatic steatosis measured with fibroscan using the controlled attenuated parameter .'}, {'measure': 'Hepatic steatosis via Fibroscan', 'timeFrame': '12 months', 'description': 'Changes in hepatic steatosis measured with fibroscan using the controlled attenuated parameter.'}, {'measure': 'Glycosylated A1C', 'timeFrame': 'Baseline', 'description': 'Glycosylated A1C in assessing metabolic comorbidity'}, {'measure': 'Glycosylated A1C', 'timeFrame': '6 months', 'description': 'Glycosylated A1C in assessing metabolic comorbidity'}, {'measure': 'Glycosylated A1C', 'timeFrame': '12 months', 'description': 'Glycosylated A1C in assessing metabolic comorbidity'}, {'measure': 'Lipid levels', 'timeFrame': 'Baseline', 'description': 'Lipid levels in assessing metabolic comorbidity'}, {'measure': 'Lipid levels', 'timeFrame': '6 months', 'description': 'Lipid levels in assessing metabolic comorbidity'}, {'measure': 'Lipid levels', 'timeFrame': '12 months', 'description': 'Lipid levels in assessing metabolic comorbidity'}, {'measure': 'Liver enzymes levels', 'timeFrame': 'Baseline', 'description': 'Liver enzymes levels for ALT, AST, and ALP'}, {'measure': 'Liver enzymes levels', 'timeFrame': '6 months', 'description': 'Liver enzymes levels for ALT, AST, and ALP'}, {'measure': 'Liver enzymes levels', 'timeFrame': '12 months', 'description': 'Liver enzymes levels for ALT, AST, and ALP'}, {'measure': 'Bilirubin level', 'timeFrame': 'Baseline', 'description': 'Liver enzyme level for Bilirubin'}, {'measure': 'Bilirubin level', 'timeFrame': '6 months', 'description': 'Liver enzyme level for Bilirubin'}, {'measure': 'Bilirubin level', 'timeFrame': '12 months', 'description': 'Liver enzyme level for Bilirubin'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nonalcoholic Fatty Liver Disease']}, 'referencesModule': {'references': [{'pmid': '37287520', 'type': 'DERIVED', 'citation': 'Hershman M, Torbjornsen K, Pang D, Wyatt B, Dieterich DT, Perumalswami PV, Branch AD, Dinani AM. Modification of the diabetes prevention program for the treatment of nonalcoholic fatty liver disease: A pilot study. Obes Sci Pract. 2022 Oct 20;9(3):218-225. doi: 10.1002/osp4.637. eCollection 2023 Jun.'}]}, 'descriptionModule': {'briefSummary': 'Nonalcoholic fatty liver disease (NAFLD) is a rapidly growing epidemic worldwide and is an increasingly important etiology of chronic liver disease and hepatocellular carcinoma. NAFLD affects approximately 90 million people in the United States (US) amounting to an annual cost of $100 billion yearly. It is projected to become the leading cause of liver transplantation in the US by 2030 and is associated with significant morbidity and mortality. NAFLD is a spectrum of liver diseases, ranging from simple steatosis (nonalcoholic fatty liver, NAFL) to hepatic steatosis associated with inflammation (nonalcoholic steatohepatitis, NASH), which can be associated with liver scarring (hepatic fibrosis) and cirrhosis. There are limited therapeutic options that have been shown to effectively reduce or reverse the progression of disease.\n\nLifestyle modification is the backbone of therapy, but difficult to achieve. A modest amount of weight loss of approximately 3% can reduce liver steatosis and a 10% weight loss can reduce the NASH and improve liver fibrosis. The American Association of the Study of Liver Diseases (AASLD) guidelines state that "a combination of a hypocaloric diet (daily reduction by 500-1000 kcal) and moderate intensity exercise is the best likelihood of sustaining weight loss over time." There are several barriers to adopting a healthy lifestyle involving both patient and physician limitations. The aim of this study is to engage patients in a lifestyle intervention program that has already been shown to be successful in achieving weight loss goals and adopting healthier lifestyle patterns.\n\nThe CDC Diabetes Prevention Program, (DPP) was a large (n=3,234) multicenter study aimed to evaluate the effect of lifestyle intervention or treatment with metformin on the incidence of type 2 diabetes (T2DM). Lifestyle intervention reduced the incidence of T2DM by 58% (95% CI, 48-66%) and metformin reduced the incidence by 31% (95% CI, 17-43%) as compared to placebo. To prevent one case of diabetes over three years, 6.9 persons would have to participate in the lifestyle-intervention program, and 13.9 would have to receive metformin. The CDC DPP program has been adapted and tested in the multiple different community and state-wide programs including the YMCA, WorkWellNYC and NYS DPP. In these real-world models, the life style intervention program has been delivered in a group-based format by DPP lifestyle coaches. These programs have been successful like that of the randomized trial and improvements were sustainable at 6 and 12 month follow up after completion of the program. The program is now available and reimbursable through Medicare (Medicare Diabetes Prevention Program).\n\nIn this pilot study, the researchers will enroll 20 patients with NAFLD in an adapted DPP program and follow study participants for 1 year. The rationale for the proposed research is to apply the DPP to NAFLD because of the close relationship with Diabetes and determine the real-world outcome of the DPP program on weight loss in patients with NAFLD. If the researchers illustrate that weight loss can be achieved and is sustainable in patients with NAFLD enrolled in lifestyle intervention programs, the researchers can develop innovative approaches to deliver such a program nationwide in a cost-effective and sustainable manner.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* diagnosis of NAFLD, defined by the presence of hepatic steatosis with vibration controlled transient elastography (VCTE) controlled attenuation parameter (CAP) measurement over 240dB/m, or liver biopsy showing macrovesicular steatosis in ≥ 5% of hepatocytes.\n* patients were 18 years and older,\n* fluent in English (the program could only be conducted in English by the DPP-certified coach),\n* able to meet program scheduling requirements, and able to participate in physical activity.\n\nExclusion Criteria:\n\n* additional causes of liver disease such as viral hepatitis, biliary obstruction, hepatocellular carcinoma, Wilson's disease, Budd Chiari Syndrome, autoimmune hepatitis, alcoholic liver disease or alcohol use (\\>20g/day women, \\>30g/day men),\n* aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values \\>300 U/L,\n* using steatogenic medications (amiodarone, methotrexate, tamoxifen, and corticosteroids),\n* pregnant,\n* a history of liver transplantation."}, 'identificationModule': {'nctId': 'NCT04988204', 'briefTitle': 'Diabetes Prevention Program for the Treatment of Nonalcoholic Fatty Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Pilot Study: Diabetes Prevention Program for the Treatment of Nonalcoholic Fatty Liver Disease', 'orgStudyIdInfo': {'id': 'GCO 18-1283'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm', 'description': 'Patients enrolled in 1 year program', 'interventionNames': ['Behavioral: Diabetes Prevention Program']}], 'interventions': [{'name': 'Diabetes Prevention Program', 'type': 'BEHAVIORAL', 'description': 'The Diabetes Prevention Program is a 1 year validated program to prevent the development of type 2 diabetes. Participants with NAFLD will engage will work with a CDC certified DPP certified lifestyle coach and other participants in a group setting during the study focusing on lifestyle changes to achieve weight loss and improvement in NAFLD.', 'armGroupLabels': ['Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Union Square', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Amreen Dinani', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine, Division of Liver Diseases'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'was not including inn protocol and consent form'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Amreen Dinani', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}