Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2026-04-08 @ 3:08 AM
Study NCT ID:
NCT06010992
Status:
UNKNOWN
Last Update Posted:
2023-08-25
First Post:
2023-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nitazoxanide as Adjuvant Therapy in Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C041747', 'term': 'nitazoxanide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-21', 'studyFirstSubmitDate': '2023-08-21', 'studyFirstSubmitQcDate': '2023-08-21', 'lastUpdatePostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic control', 'timeFrame': '12 weeks', 'description': 'Fasting blood glucose and glycated hemoglobin'}], 'secondaryOutcomes': [{'measure': 'Insulin resistance', 'timeFrame': '12 weeks', 'description': 'fasting insulin level with HOMA-IR calculation'}, {'measure': 'Lipid profile', 'timeFrame': '12 weeks', 'description': 'Serum levels of total cholesterol, LDL, HDL, and triglycerides'}, {'measure': 'Serum levels of A-kinase anchoring protein 1', 'timeFrame': '12 weeks'}, {'measure': 'Serum levels of asprosin', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '40815384', 'type': 'DERIVED', 'citation': 'Ghonaim EM, Ibrahim OM, Hegazy SK, Farrag WF, Badr HR. Repurposing nitazoxanide in type 2 diabetes mellitus: a randomized controlled trial. Endocrine. 2025 Nov;90(2):596-604. doi: 10.1007/s12020-025-04387-5. Epub 2025 Aug 15.'}]}, 'descriptionModule': {'briefSummary': 'Diabetes mellitus (DM) is a complex metabolic disorder characterized by hyperglycemia and abnormalities in carbohydrate, fat, and protein metabolism. Despite the advancement in anti-diabetic drug therapy, most patients fail to achieve optimal glycemic control. This highlights the need for more effective strategies to control type 2 diabetes mellitus.\n\nNitazoxanide (NTZ), a broad-spectrum anti-infective drug with activity against various protozoa, helminthes, bacteria, and viruses, was identified as peroxisome proliferative activated receptor gamma (PPARγ) agonist using one dimensional drug profile matching. Additionally, it improved insulin sensitivity in insulin-resistant type 2 diabetic rats. Therefore, this study is designed to evaluate the efficacy of nitazoxanide as adjunctive therapy in patients with type 2 diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Glycated hemoglobin (HbA1c) between 7% and 9%.\n* Body mass index ≥ 25 kg/m2\n\nExclusion Criteria:\n\n* Pregnant or nursing women.\n* Type 1 diabetes mellitus.\n* Liver disease (alanine aminotransferase \\> 3 upper normal limit).\n* Kidney disease (estimated glomerular filtration rate \\< 60 ml/min/1.73 m2).\n* Inflammatory bowel diseases.\n* History of allergy and/or adverse reactions to the drugs used in the study.'}, 'identificationModule': {'nctId': 'NCT06010992', 'briefTitle': 'Nitazoxanide as Adjuvant Therapy in Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'A Clinical Study Evaluating the Potential Benefit of Nitazoxanide in Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '36264MD53/3/23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group 1', 'description': '35 Patients with type 2 diabetes receiving treatment with metformin and dipeptidyl peptidase-4 (DPP-4) inhibitors (such as vildagliptin).'}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': '35 Patients with type 2 diabetes receiving nitazoxanide 500 mg orally twice daily in addition to metformin and dipeptidyl peptidase-4 (DPP-4) inhibitors (such as vildagliptin).', 'interventionNames': ['Drug: Nitazoxanide']}], 'interventions': [{'name': 'Nitazoxanide', 'type': 'DRUG', 'description': 'Nitazoxanide oral capsules 500 mg twice daily', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Eman Ghonaim', 'role': 'CONTACT', 'email': 'eman.ghonim@pharm.tanta.edu.eg', 'phone': '+20-010-970-821-57'}], 'facility': 'Faculty of medicine, Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}, {'zip': '32511', 'city': 'Shibīn al Kawm', 'state': 'Menoufia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Eman Ghonaim', 'role': 'CONTACT', 'email': 'eman.ghonim@pharm.tanta.edu.eg', 'phone': '+20-010-970-812-57'}], 'facility': 'Faculty of Medicine, Menoufia University', 'geoPoint': {'lat': 30.55258, 'lon': 31.00904}}], 'centralContacts': [{'name': 'Eman Ghonaim, Assistant lecturer', 'role': 'CONTACT', 'email': 'eman.ghonim@pharm.tanta.edu.eg', 'phone': '+20-010-970-821-57'}], 'overallOfficials': [{'name': 'Eman Ghonaim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Lecturer, Faculty of Pharmacy, Tanta University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Menoufia University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Eman Ghonaim', 'investigatorAffiliation': 'Tanta University'}}}}