Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-31 @ 11:36 AM
Study NCT ID:
NCT04766450
Status:
UNKNOWN
Last Update Posted:
2022-08-08
First Post:
2021-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of High-Dose NAC on Patients With DPN
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003929', 'term': 'Diabetic Neuropathies'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-04', 'studyFirstSubmitDate': '2021-02-13', 'studyFirstSubmitQcDate': '2021-02-21', 'lastUpdatePostDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Michigan neuropathy screening instrument.', 'timeFrame': 'At baseline and after 3 months', 'description': 'Questionnaire of 15 yes or no questions. score of 13 or more means more neuropathic symptoms'}, {'measure': 'Toronto clinical scoring system', 'timeFrame': 'At baseline and after 3 months', 'description': 'Questionnaire. as score increase means symptoms increase'}], 'primaryOutcomes': [{'measure': 'Concentration of Human Nuclear factor erythroid 2-related factor (NRF2)', 'timeFrame': 'change from baseline Human Nuclear factor erythroid 2-related factor at 3 months', 'description': 'Inflammatory marker'}, {'measure': 'Concentration of Tumor necrosis factor alpha', 'timeFrame': 'Change from baseline tumor necrosis factor alpha at 3 months', 'description': 'Inflammatory marker'}, {'measure': 'Concentration of Glutathione peroxidase', 'timeFrame': 'Change from baseline glutathione peroxidase at 3 months', 'description': 'Oxidative stress markers'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Neuropathies']}, 'referencesModule': {'references': [{'pmid': '40038825', 'type': 'DERIVED', 'citation': 'Emara SM, Fahmy SF, AbdelSalam MM, Wakeel LME. Effect of high-dose N-acetyl cysteine on the clinical outcome of patients with diabetic peripheral neuropathy: a randomized controlled study. Diabetol Metab Syndr. 2025 Mar 4;17(1):79. doi: 10.1186/s13098-025-01624-9.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1016/j.tips.2013.01.001', 'label': 'Berk, M., Malhi, G. S., Gray, L. J., \\& Dean, O. M. (2013). The promise of N-acetylcysteine in neuropsychiatry. Trends in Pharmacological Sciences, 34(3), 167-177.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the current study is to evaluate the efficacy and safety of high dose oral NAC (2400 mg/day divided into two doses) as an adjunct therapy on oxidative stress, inflammatory markers and clinical outcome in patients with type 2 diabetes suffering from diabetic peripheral neuropathy.', 'detailedDescription': 'Patient written informed consent will be taken prior to study conductance\n\n* Lab assessment will be done at baseline and at the end of the study by withdrawing 7 ml of whole blood for assessment of following parameters: HbA1c, Liver \\& renal functions\n* Inflammatory markers including: Human Nuclear factor erythroid 2-related factor (NRF2) \\& Tumor necrosis factor alpha (TNF-α) using ELISA Kit\n* Oxidative stress markers: Glutathione Peroxidase using ELISA Kit\n\nInflammatory and oxidative stress marker samples will be stored at -80 for further evaluation using ELISA kit at the end of the study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males or females aged 18-50 years diagnosed with Type 2 Diabetes taking oral hypoglycemic with controlled at HbA1c (6%-7%.)\n2. Patients diagnosed with Diabetic Neuropathy (by pinprick, temperature probe, ankle reflex, and vibration perception (128-Hz tuning fork) or pressure sensation (10 g monofilament test).\n\nExclusion Criteria:\n\n1. Patients with acute and chronic inflammatory conditions, consuming any antioxidant supplements or anti-inflammatory medicines.\n2. Pregnancy or lactation or expecting to get pregnant during the study.\n3. Medical, psychological, or pharmacological factors interfering with the collection or interpretation of study data.\n4. Cancer patients.\n5. Anyone having hypersensitivity to N-acetylcysteine.\n6. Anyone already taking N-acetylcysteine.'}, 'identificationModule': {'nctId': 'NCT04766450', 'acronym': 'NAC', 'briefTitle': 'Effect of High-Dose NAC on Patients With DPN', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Effect of High-Dose N-acetyl Cysteine (NAC) on the Inflammatory Markers and Clinical Outcome of Patients With Diabetic Peripheral Neuropathy (DPN)', 'orgStudyIdInfo': {'id': 'NAC in DPN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1, NAC group', 'description': 'Group 1, NAC group (n=30): Patients will receive conventional therapy for diabetic neuropathy in addition to High Dose N-acetyl cysteine (2400 mg/day divided into two doses) daily for 3 months', 'interventionNames': ['Drug: Acetyl cysteine']}, {'type': 'NO_INTERVENTION', 'label': 'Group 2, Control group', 'description': 'Group 2, Control group (n= 30): Patients will receive conventional therapy for diabetic neuropathy alone for 3 months.'}], 'interventions': [{'name': 'Acetyl cysteine', 'type': 'DRUG', 'otherNames': ['N-acetyl cysteine'], 'description': 'NAC exhibits potent anti-oxidant activity in the cell through augmentation of intracellular GSH, which is a major component of the pathways by which cells are protected from OTS, and its direct scavenging activity of free radicals by providing sulfhydryl groups. Additionally, NAC treatment exhibits anti-inflammatory effects via inhibition of NF-κB activation and reducing subsequent cytokine production . Mitochondria-protective mechanisms of NAC may also be related to its anti-oxidant and anti-inflammatory properties', 'armGroupLabels': ['Group 1, NAC group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mona AbdelSalam, Professor', 'role': 'CONTACT'}], 'facility': 'Demerdash Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Sherien Emara, TA', 'role': 'CONTACT', 'email': 'sherienemara@hotmail.com', 'phone': '01154089169'}, {'name': 'Sara Farid Mohamed, Lecturer', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Lamia El Wakeel, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teaching Assistant', 'investigatorFullName': 'Sherien Emara', 'investigatorAffiliation': 'Ain Shams University'}}}}