Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-28 @ 10:48 AM
Study NCT ID:
NCT01083992
Status:
UNKNOWN
Last Update Posted:
2011-04-28
First Post:
2010-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Vitagliptin and Vitamin D in the Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077597', 'term': 'Vildagliptin'}, {'id': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-04-27', 'studyFirstSubmitDate': '2010-03-08', 'studyFirstSubmitQcDate': '2010-03-09', 'lastUpdatePostDateStruct': {'date': '2011-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'decrease in histological findings', 'timeFrame': '6 months', 'description': 'decrease in histological findings: decrease in fat concentration and fibrosis degree'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['NAFLD', 'Galvus', 'vitamin D'], 'conditions': ['Non-Alcoholic Fatty Liver Disease']}, 'descriptionModule': {'briefSummary': 'Sedentary lifestyle and poor dietary choices are leading to a weight gain epidemic and increasing the risk for developing nonalcoholic fatty liver disease (NAFLD). The strong relationship between insulin resistance and NAFLD suggests that adding Vitamin D TO insulin sensitizing therapies such as Galvus (vitagliptin) might be beneficial in the prevention or improvement in NAFLD. Considering the close relationship between NAFLD and T2DM and lipid metabolism, we assume that adding vitamin D to Galvus, may be effective for NAFLD by improving lipid metabolism and by improving type 2 diabetes mellitus (T2DM).', 'detailedDescription': 'Sedentary lifestyle and poor dietary choices are leading to a weight gain epidemic and increasing the risk for developing nonalcoholic fatty liver disease (NAFLD). The strong relationship between insulin resistance and NAFLD suggests that adding vitamin D to insulin sensitizing therapies such as Galvus (vitagliptin) might be beneficial in the prevention or improvement in NAFLD. Considering the close relationship between NAFLD and T2DM and lipid metabolism, we assume that adding vitamin D to Galvus may be effective for NAFLD by improving lipid metabolism and by improving T2DM. Methods: 60 patients with NAFLD (Diagnosed by Ultrasound, increase ALT level and hepatomegaly) will be enrolled, and divided into 2 arms Galvus plus Vitamin D vs. Galvus alone. Biochemistry, hepatic triglycerides, histology, m RNA gene expression of collagen, MTP, SREP-1, PPAR-alpha, and LDLR will be measured. 2 separate liver biopsies will be performed at screening and 6 months from baseline. Expected results: Long-term combination therapy with vitagliptin and Vitamin D significantly reduced steatosis, inflammation and fibrosis in the liver compared with long-term monotherapy. We expect also that the combination therapy also significantly increased the expression of microsomal triglyceride transfer protein (MTP) and peroxisome proliferators-activated receptor-α1 (PPAR-α1) in the liver, compared with monotherapy, which may have lead to the improvement in lipid metabolic disorder . Conclusion: Combination therapy of vitagliptin and vitamin D, for 24 weeks improve the histopathology findings in NAFLD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years old\n* Men and women with NAFLD per US\n* Increased ALT level\n* Hepatomegaly\n* Liver biopsy within 2 years\n\nExclusion Criteria:\n\n* Other liver diseases (HBV, HCV)\n* Hepatocellular carcinoma\n* Decompensated liver disease\n* Use of steroids'}, 'identificationModule': {'nctId': 'NCT01083992', 'briefTitle': 'Role of Vitagliptin and Vitamin D in the Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ziv Hospital'}, 'officialTitle': 'Role of Vitagliptin and Vitamin D in the Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)', 'orgStudyIdInfo': {'id': 'NAFLD+ Vitamin D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Galvus + vitamin D', 'description': 'Galvus in combination with vitamin D', 'interventionNames': ['Drug: Galvus + vitamin D']}, {'type': 'OTHER', 'label': 'Galvus', 'description': 'vitagliptin as monotherapy', 'interventionNames': ['Drug: Galvus (vitagliptin)']}], 'interventions': [{'name': 'Galvus (vitagliptin)', 'type': 'DRUG', 'description': 'Galvus (vitagliptin)', 'armGroupLabels': ['Galvus']}, {'name': 'Galvus + vitamin D', 'type': 'DRUG', 'description': 'Galvus + vitamin D', 'armGroupLabels': ['Galvus + vitamin D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13100', 'city': 'Safed, Israel', 'country': 'Israel', 'contacts': [{'name': 'Nimer Assy, MD', 'role': 'CONTACT', 'email': 'assy.n@ziv.health.gov.il', 'phone': '+972-46828445'}], 'facility': 'Ziv medical center liver unit', 'geoPoint': {'lat': 32.96465, 'lon': 35.496}}], 'centralContacts': [{'name': 'Assy Nimer, MD', 'role': 'CONTACT', 'email': 'ASSY.N@ZIV.HEALTH.GOV.IL', 'phone': '+97246828445'}], 'overallOfficials': [{'name': 'Nimer Assy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ZIV MEDICAL CENTER, SAFED ISRAEL'}, {'name': 'ASSY NIMER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ziv medical center safed, israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziv Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Liver Clinic', 'oldOrganization': 'Ziv medical center'}}}}