Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-30 @ 6:01 PM
Study NCT ID:
NCT05586932
Status:
UNKNOWN
Last Update Posted:
2022-10-19
First Post:
2022-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxidative Stress and Iron Overload in Patient With Abnormal Haemoglobinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-16', 'studyFirstSubmitDate': '2022-10-16', 'studyFirstSubmitQcDate': '2022-10-16', 'lastUpdatePostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correlation between oxidative stress and endocrine dysfunction in patients with hemoglubinopathy', 'timeFrame': '1 year', 'description': '1. The effects of iron overload and oxidative stress and dyslipidemia on glucose level and thyroid function in patients with abnormal hemoglobinopathy.'}], 'secondaryOutcomes': [{'measure': 'Using of MDA level as a marker of oxidative stress', 'timeFrame': '1 year', 'description': 'Malondialdehyde as a marker of oxidative stress'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oxidative Stress in Patient With Haemoglobinopathy and Affect it of Endocrine System']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/32020146/', 'label': 'Endocrinopathies complicating transfusion-dependent hemoglobinopathy'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/32900239/', 'label': 'Pituitary Iron Deposition and Endocrine Complications in Patients with β-Thalassemia: From Childhood to Adulthood'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/33669171/', 'label': 'Sickle Cell Disease: Role of Oxidative Stress and Antioxidant Therapy'}]}, 'descriptionModule': {'briefSummary': 'The effects of iron overload and oxidative stress and dyslipidemia on glucose level and thyroid function in patients with abnormal hemoglobinopathy. 2- Evaluation of MDA level as a marker of oxidative stress.', 'detailedDescription': "Severe anemia due to defect in the synthesis of hemoglobin and hemolysis can endanger the life of β- thalassemia major (β-TM) patients and sickle cell anemia; therefore, the span and patient's quality of life is highly dependent on regular blood transfusion. Nonetheless, blood transfusion causes iron accumulation in the patients. Excess iron deposits in vital organs, such as liver, heart and endocrine glands, result in their malfunction. Endocrinopathies account as one of the most common iron overload complications. Oxidative stress is a major mechanism contributing to the progression of the disease in TDT. Iron overload enhances oxidative stress in patients with TDT. Iron is recognized to be a catalyst in developing reactive oxygen species (ROS).\n\nMDA is an eosinophilic enol compound that reacts with the structural and functional cellular protein to generate toxic lipoxidation end product destined for cellular damage of the affected organs. It is used as a sensitive biomarker for oxidative stress. Disturbances in serum lipids and carbohydrates homoeostasis as well as OS were documented in β-TM and sickle cell anemia. Increase in serum levels total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and decrease in high-density lipoprotein cholesterol (HDL-C) are the well-known causative factors and predictors of CHD development and endocrine abnormality"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will be done in Assiut University Hospital on 50 cases as Group (A): cases diagnosed as beta thalassemia major Group (B): healthy individuals (control)\n\nAll patients will be subjected to full clinical history, examination and investigation. -investigation will include:\n\n* laboratory test:\n* CBC. -TSH, T4, T3. -serum oxidative stress marker (MDA).\n* glucose level.\n* cholesterol, triglycerides, HDl, LDL', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- age 18 and above.\n\n-patients diagnosed according to physical examination and results of laboratory tests as beta thalassemia major. -patient under gradual blood transfusion and iron chelating therapy. -Gender and age matched healthy controls with normal serum lipid, glucose level and thyroid function will enrolled in this study as the control group\n\nExclusion Criteria:\n\n* age under 18 years.\n* patient diagnosed with DM or those taking pharmacological agents such as steroids, insulin and lipid lowering drugs'}, 'identificationModule': {'nctId': 'NCT05586932', 'briefTitle': 'Oxidative Stress and Iron Overload in Patient With Abnormal Haemoglobinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Effect of Iron Overload, Oxidative Stress and Dyslipidemia on Glucose Level and Thyroid Function in Patients With Abnormal Hemoglobinopathy', 'orgStudyIdInfo': {'id': 'OxidativestressinabnormalHb'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Samar Gebril Mahdy, Intern', 'role': 'CONTACT', 'email': 'samargebril654321@gmail.com', 'phone': '+0201015714015'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Samar Gebril Mohamed Mahdy', 'investigatorAffiliation': 'Assiut University'}}}}