Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-02-25 @ 10:05 PM
Study NCT ID:
NCT02947568
Status:
UNKNOWN
Last Update Posted:
2019-02-25
First Post:
2016-09-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetical Background of Non-alcoholic Fatty Liver Disease (NAFLD) in Diabetes Mellitus and in Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-22', 'studyFirstSubmitDate': '2016-09-22', 'studyFirstSubmitQcDate': '2016-10-25', 'lastUpdatePostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association of NFS (NAFLD fibrosis score) and HSI (hepatic steatosis index) with underlying conditions', 'timeFrame': '2 years', 'description': 'The association of hepatic steatosis with chronic kidney disease, diabetes mellitus and the the persence of these two will be assessed'}, {'measure': 'Association of genetical factors with NFS and HSI', 'timeFrame': '2 years', 'description': 'The association of hepatic steatosis with genetic factors will be assessed. In case of patatin-like phospholipase domain-containing protein 3 gene (PNPLA3) : rs738409, rs2281135, rs2294918 single nuclear polimorfism (SNP) will be examined'}], 'secondaryOutcomes': [{'measure': 'Association of hepatic steatosis with renal function', 'timeFrame': '2 years', 'description': 'The association of serum creatinine, eGFR, blood urea nitrogen, serum sodium, serum potassium, serum calcium with NFS and HSI will be assessed'}, {'measure': 'Association of glucose metabolism parameters with hepaic steatosis indices', 'timeFrame': '2 years', 'description': 'Association of HbA1C, fructosamine, blood glucose, serum insulin, HOMAIR, serum uric acid with NFS and HSI'}, {'measure': 'Association of liver function and hepatic setatosis indices', 'timeFrame': '2 years', 'description': 'Association of serum bilirubine, serum GOT, serum GPT, serum GGT, serum ALP, serum LDH, INR, serum total protein, serum albumin with NFS and HSI'}, {'measure': 'Association of serum lipid profile and hepatic setatosis indices', 'timeFrame': '2 years', 'description': 'Association of serum total cholesterol, serum HDL-cholesterol, serum LDL-cholesterol, serum triglyceride, serum carnitine with NFS and HSI'}, {'measure': 'Association of iron metabolism parameters with hepatic setatosis indices', 'timeFrame': '2 years', 'description': 'association of serum iron, serum transferrine, serum transferrine saturation, serum ferritine with NFS and HSI'}, {'measure': 'The relationship between blood count, sedimentation and inflammation with hepatic setatosis indices', 'timeFrame': '2 years', 'description': 'Association of blood count, erythrocyte sedimentation rate, CRP with NFS and HSI'}, {'measure': 'Assotion of serum proteins with hepatic setatosis indices', 'timeFrame': '2 years', 'description': 'association of urinary total protein, urinary albumin, urinary total protein/creatinine ratio, urinary albumin/creatinine ratio with NFS and HSI'}, {'measure': 'Association of pathological tyrosine isoforms with hepatic setatosis indices', 'timeFrame': '2 years', 'description': 'Association of serum meta-Tyr, serum ortho-Tyr, urinary meta-Tyr, urinary ortho-Tyr, urinary meta-Tyr/creatinine ratio, urinary ortho-Tyr/creatinine ratio with NFS and HSI'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Non-alcoholic Fatty Liver Disease', 'Chronic Kidney Disease', 'Diabetes Mellitus', 'Cross-sectional'], 'conditions': ['Non-alcoholic Fatty Liver Disease', 'Chronic Kidney Disease', 'Diabetes Mellitus']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '1. Alp H, Karaarsian S, Selver EB,Atabek ME, Altin H, Baysal T. Association between nonalcoholic fatty liver disease and cardiovascular risk in obese children and adolescents. Can J Cardiol 2013;29:1118-1125. 2. Byrne CD, Targher G: NAFLD: A multisystem disease. Review. Journal of Hepatology, 2015; 62:S47-S64. 3. Kasturiratne A, Weerasinghe S, Dassanayake AS, rajindrajith S, de Silva AP, Kato N, et al. Influence of non-alcoholic fatty liver disease on the development of diabetes mellitus. J Gastroenterol Hepatol 2013;60:384-391. 4. Li G, Shi W, Hug H, Chen Y, Liu L, Yin D. Nonalcoholic fatty liver disease associated with impairment of kidney function in nondiabetes population. Biochem Med 2012;22:92-99. 5. Okamoto M, Takeda Y, Yoda Y, Kobayashi K, Fujino MA, Yamagata Z. The association of fatty liver and diabetes risk. J Epidemiol 2003;13:15-21. 6. Pacifico L, Di MM, De MA, Bezzi M, Osborn JF, Catalano C, et al. Left ventricular dysfunction in obese children and adolescents with nonalcoholic fatty liver disease. Hepatology 2014;59:461-470. 7. Targher G, Choncol MB, Byrne CD. CKD a nonalcoholic fatty liver disease. Am J Kidney Dis 2014;64:638-652. 8. Wood KL, Miller MH, Dillon JF. systematic review of genetic association studies involving histologically confirmed non-alcoholic fatty liver disease BMJ Open Gastro 2015:2:e000019. doi10.1136/bmjgast-2014-000019 9. Zain SM, Mohamed R, Hyogo H, et al. A multi-ethnic study of a PNPLA3 variant and its association with disease severity in non-alcoholic fatty liver disease. Hum genet 2012;131:1145-1152. 10. Zuppini G, Fedeli U, Gennaro N, Saugo M, Targher G, Bonora E. Mortality from chronic liver diseases in diabetes. Am J Gastroenterol 2014;109:1020-1025.'}]}, 'descriptionModule': {'briefSummary': 'The present study investigates relationship between non-alcoholic fatty liver disease and its risk factors, such as genetic background and diseases, such as chronic kidney disease and diabetes mellitus.', 'detailedDescription': 'Non-alcoholic fatty liver disease (NAFLD) is a multisystemic disease, also affecting extrahepatic organs (1,2,6). According to former data, not only the prevalence of chronic hepatic disease, chronic cardiovascular diseases, but also the prevalence of chronic kidney disease (CKD) is higher in NAFLD (4,7). A strong association has been shown between diabetes mellitus (DM) and NAFLD as well (3,5,10).\n\nMany genetical factors have been studied in the background of NAFLD. Many studies have proved the effect of patatin-like phospholipase domain-containing protein 3 gene (PNPLA3) (8,9). Effect of numerous genetical polymorphisms has been suggested behind oxidative stress responsible for NAFLD (8).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with CKD without DM, or patients with DM without CKD, or patients with both CKD and DM, aged 18-90', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CKD (renal replacement therapy non excluded)\n* DM\n* CKD+DM\n\nExclusion Criteria:\n\n* alcohol abuse'}, 'identificationModule': {'nctId': 'NCT02947568', 'acronym': 'NAFLDDMCKD', 'briefTitle': 'Genetical Background of Non-alcoholic Fatty Liver Disease (NAFLD) in Diabetes Mellitus and in Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Pecs'}, 'officialTitle': 'Genetical Background of Non-alcoholic Fatty Liver Disease (NAFLD) in Diabetes Mellitus and in Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'Pecs_NAFLD_01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CKD', 'description': 'chronic kidney disease', 'interventionNames': ['Other: non-interventional study']}, {'label': 'DM', 'description': 'diabetes mellitus', 'interventionNames': ['Other: non-interventional study']}, {'label': 'CKD+DM', 'description': 'chronic kidney disease + diabetes mellitus', 'interventionNames': ['Other: non-interventional study']}], 'interventions': [{'name': 'non-interventional study', 'type': 'OTHER', 'armGroupLabels': ['CKD', 'CKD+DM', 'DM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7624', 'city': 'Pécs', 'state': 'Baranya', 'country': 'Hungary', 'facility': '2nd Department of Medicine and Nephrological Center', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pecs', 'class': 'OTHER'}, 'collaborators': [{'name': 'Teaching Hospital Markusovszky, Szombathely', 'class': 'UNKNOWN'}, {'name': 'Fresenius Medical Care North America', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Dr. Gergő Molnár', 'investigatorAffiliation': 'University of Pecs'}}}}