Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-10 @ 6:45 PM
Study NCT ID:
NCT06589167
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-08-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Syndrome and Fatty Liver Disease Among Egyptian Patients with Chronic HBV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D005234', 'term': 'Fatty Liver'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-05', 'studyFirstSubmitDate': '2024-08-09', 'studyFirstSubmitQcDate': '2024-09-05', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'investigate the Prevalence of combined hepatic steatosis in patients with chronic HBV', 'timeFrame': 'baseline'}], 'secondaryOutcomes': [{'measure': 'evaluate clinical characteristics of chronic HBV patients combined with metabolic syndrome and hepatic steatosis', 'timeFrame': 'baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metabolic syndrome', 'Nonalcoholic fatty liver disease', 'hepatic steatosis'], 'conditions': ['Metabolic Syndrome', 'Fatty Liver Disease']}, 'referencesModule': {'references': [{'pmid': '35620544', 'type': 'BACKGROUND', 'citation': 'Mohammed H, Eshetie A, Melese D. Prevalence of hepatitis B virus and associated risk factors among adults patients at Dessie referral and Kemise general hospitals in northeastern Ethiopia. Health Sci Rep. 2022 May 22;5(3):e659. doi: 10.1002/hsr2.659. eCollection 2022 May.'}, {'pmid': '26622990', 'type': 'BACKGROUND', 'citation': 'Bhat M, Ghali P, Deschenes M, Wong P. Prevention and Management of Chronic Hepatitis B. Int J Prev Med. 2014 Dec;5(Suppl 3):S200-7.'}, {'pmid': '25473721', 'type': 'BACKGROUND', 'citation': 'National Clinical Guideline Centre (UK). Hepatitis B (Chronic): Diagnosis and Management of Chronic Hepatitis B in Children, Young People and Adults. London: National Institute for Health and Care Excellence (UK); 2013 Jun. Available from http://www.ncbi.nlm.nih.gov/books/NBK254250/'}, {'pmid': '29083742', 'type': 'BACKGROUND', 'citation': 'Swarup S, Ahmed I, Grigorova Y, Zeltser R. Metabolic Syndrome. 2024 Mar 7. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK459248/'}, {'pmid': '33075830', 'type': 'BACKGROUND', 'citation': 'Bovolini A, Garcia J, Andrade MA, Duarte JA. Metabolic Syndrome Pathophysiology and Predisposing Factors. Int J Sports Med. 2021 Mar;42(3):199-214. doi: 10.1055/a-1263-0898. Epub 2020 Oct 19.'}, {'pmid': '24582089', 'type': 'BACKGROUND', 'citation': 'Samson SL, Garber AJ. Metabolic syndrome. Endocrinol Metab Clin North Am. 2014 Mar;43(1):1-23. doi: 10.1016/j.ecl.2013.09.009.'}, {'pmid': '34513789', 'type': 'BACKGROUND', 'citation': 'Aboulghate M, Elaghoury A, Elebrashy I, Elkafrawy N, Elshishiney G, Abul-Magd E, Bassiouny E, Toaima D, Elezbawy B, Fasseeh A, Abaza S, Voko Z. The Burden of Obesity in Egypt. Front Public Health. 2021 Aug 27;9:718978. doi: 10.3389/fpubh.2021.718978. eCollection 2021.'}, {'pmid': '36517002', 'type': 'BACKGROUND', 'citation': 'Teng ML, Ng CH, Huang DQ, Chan KE, Tan DJ, Lim WH, Yang JD, Tan E, Muthiah MD. Global incidence and prevalence of nonalcoholic fatty liver disease. Clin Mol Hepatol. 2023 Feb;29(Suppl):S32-S42. doi: 10.3350/cmh.2022.0365. Epub 2022 Dec 14.'}, {'pmid': '36544761', 'type': 'BACKGROUND', 'citation': 'Tourkochristou E, Assimakopoulos SF, Thomopoulos K, Marangos M, Triantos C. NAFLD and HBV interplay - related mechanisms underlying liver disease progression. Front Immunol. 2022 Dec 5;13:965548. doi: 10.3389/fimmu.2022.965548. eCollection 2022.'}, {'pmid': '36726053', 'type': 'BACKGROUND', 'citation': 'Huang SC, Liu CJ. Chronic hepatitis B with concurrent metabolic dysfunction-associated fatty liver disease: Challenges and perspectives. Clin Mol Hepatol. 2023 Apr;29(2):320-331. doi: 10.3350/cmh.2022.0422. Epub 2023 Feb 1.'}, {'pmid': '37770837', 'type': 'BACKGROUND', 'citation': 'Dai YN, Xu CF, Pan HY, Chen MJ, Yu CH. Fatty liver is associated with significant liver inflammation and increases the burden of advanced fibrosis in chronic HBV infection. BMC Infect Dis. 2023 Sep 28;23(1):637. doi: 10.1186/s12879-023-08632-y.'}, {'pmid': '37157776', 'type': 'BACKGROUND', 'citation': 'Wong YJ, Nguyen VH, Yang HI, Li J, Le MH, Wu WJ, Han NX, Fong KY, Chen E, Wong C, Rui F, Xu X, Xue Q, Hu XY, Leow WQ, Goh GB, Cheung R, Wong G, Wong VW, Yu MW, Nguyen MH. Impact of fatty liver on long-term outcomes in chronic hepatitis B: a systematic review and matched analysis of individual patient data meta-analysis. Clin Mol Hepatol. 2023 Jul;29(3):705-720. doi: 10.3350/cmh.2023.0004. Epub 2023 May 8.'}, {'pmid': '36747946', 'type': 'BACKGROUND', 'citation': 'Liu L, Li H, Zhang Y, Zhang J, Cao Z. Hepatitis B virus infection combined with nonalcoholic fatty liver disease: Interaction and prognosis. Heliyon. 2023 Jan 20;9(1):e13113. doi: 10.1016/j.heliyon.2023.e13113. eCollection 2023 Jan.'}]}, 'descriptionModule': {'briefSummary': '1. investigate the Prevalence of combined hepatic steatosis in patients with chronic HBV.\n2. to evaluate clinical characteristics of chronic HBV patients combined with metabolic syndrome and hepatic steatosis', 'detailedDescription': "* Hepatitis B virus (HBV) infection is a major global health problem, with an estimated 290 million infections worldwide. The estimated prevalence of HBV is about 1.4% in Egypt.\n* Chronic hepatitis B describes a spectrum of disease usually characterised by the presence of detectable hepatitis B surface antigen (HbsAg) in the blood or serum for longer than 6 months. In some people, chronic hepatitis B is inactive and does not present significant health problems, but others may progress to liver fibrosis, cirrhosis and hepatocellular carcinoma (HCC). The progression of liver disease is associated with hepatitis B virus (HBV) DNA levels in the blood. The presence of HbeAg is typically associated with higher rates of viral replication and therefore increased infectivity.\n* Metabolic syndrome is an accumulation of several disorders that includes central obesity, insulin resistance, hypertension, and atherogenic dyslipidemia .These disorders raise the risk of atherosclerotic cardiovascular disease, including myocardial infarction, cerebrovascular accidents, peripheral vascular diseases, insulin resistance, and type II diabetes mellitus.\n* Obesity causes an estimated 4.7 million premature deaths per year. It was the fifth greatest preventable cause of death in 2017, accounting for 8.4% of all deaths worldwide. Egypt ranks 18th with the highest prevalence of obesity in the world.44.7% of adult women and 25.9% of adult men are living with obesity. Egypt's obesity prevalence is higher than the regional average of 20.8% for women and 9.2% for men.\n* Nonalcoholic fatty liver disease (NAFLD) is a leading cause of liver disease worldwide.The estimated global prevalence of NAFLD among adults is 32% and is higher among males (40%) compared to females (26%) .NAFLD is defined as the presence of steatosis (i.e. more than 5% liver fat content) without coexisting etiologies of secondary steatosis such as alcohol abuse and drug-induced liver injury .\n* Dysregulated fatty acid metabolism and lipotoxicity in NAFLD disease initiate activation of signaling pathways that enhance pro-inflammatory responses and disrupt hepatocyte cell homeostasis, promoting progression of NAFLD disease to NASH(Non Alcoholic Steatohepatitis), fibrosis and HCC and can affect HBV replication and immune encountering of HBV virus, which may further have impact on liver disease progression .Chronic HBV infection is suggested to have an influence on metabolic changes, which could lead to NAFLD development and the HBV-induced inflammatory responses and molecular pathways may constitute an aggravating factor in hepatic steatosis development. The altered immune homeostasis in both HBV infection and NAFLD could be associated with progression to HCC development."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'total coverage of all patients with HBV aged 18-60 years,not combined with HCV or HIV.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age above 18 years.\n\nExclusion Criteria:\n\n* Age below 18 years.\n* Patients with combined HBV,HCV,HIV.\n* Patients refused to contribute in this study.'}, 'identificationModule': {'nctId': 'NCT06589167', 'briefTitle': 'Metabolic Syndrome and Fatty Liver Disease Among Egyptian Patients with Chronic HBV', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Metabolic Dysfunction Among Egyptian Patients with Chronic HBV', 'orgStudyIdInfo': {'id': 'Metabolic syndrome and NAFLD'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hadeer A Abd El-Sattar', 'role': 'CONTACT', 'email': 'mohammedhadeer101@gmail.com', 'phone': '01025454235'}, {'name': 'Ghada A Abdel rahman', 'role': 'CONTACT', 'email': 'ghadaa1980@aun.edu.eg', 'phone': '01004301177'}], 'overallOfficials': [{'name': 'Hadeer Abd El-Sattar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}, {'name': 'Ghadaa Abdel rahman', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Bahaa Osman Taha', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident doctor', 'investigatorFullName': 'Hadeer Abd EL-Sattar Mohammed', 'investigatorAffiliation': 'Assiut University'}}}}