Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-25 @ 8:56 PM
Study NCT ID:
NCT06073756
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-10
First Post:
2023-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neutrophil-lymphocyte and Platelet-lymphocyte Ratios and Their Relations to Vascular Comlications and Glycemic Control in Patients With Type 2 Diabetes Attending The Diabetes Center of Assiut University Hospitals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000418', 'term': 'Albumins'}, {'id': 'D009431', 'term': 'Neural Conduction'}, {'id': 'D059552', 'term': 'Caves'}], 'ancestors': [{'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D055724', 'term': 'Electrophysiological Phenomena'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D055593', 'term': 'Geological Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-03', 'studyFirstSubmitDate': '2023-10-03', 'studyFirstSubmitQcDate': '2023-10-03', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neutrophil-to-lymphocyte ratio and platelets to lymphocytes ratio', 'timeFrame': 'Basline', 'description': 'Measurement of Neutrophils to lymhocyte ratio and platelets to lymhocyte ratio in patients with type 2 DM'}], 'secondaryOutcomes': [{'measure': 'HbA1c with good glycemic control and have HBA1C lower than 7and poor glycemic control and have HBA1C higher than 7with prescence or abscence of vascular complications', 'timeFrame': 'Basline', 'description': 'Evaluate PLR and NLR and their assiotation to vascular complications and glycemic control in type 2 DM'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neutrophils to lymhocyte ratio and platelets to lymhocyte ratio'], 'conditions': ['Vascular Complication, Diabetic']}, 'descriptionModule': {'briefSummary': 'Evaluate PLR and NLR and their assiotation to vascular complications and glycemic control in type 2 DM', 'detailedDescription': 'Vascular complications of DM result from various disorders including metabolic, cellular, and blood disturbances. Excessive production of pro-inflammatory adipokines from adipose tissue, resulting in low-grade chronic inflammation, causing insulin resistance (IR) and type 2 DM \\[3\\]. Hematological changes affecting the red blood cells (RBCs), white blood cells (WBCs), platelet function, and the coagulation factors are detected to be associated with DM . It is important to add that, high WBC count, one of the chief components of inflammatory process, sharing to atheroscle-rosis development and cardiovascular diseases (CVD) . Lately, the neutrophil-to-lymphocyte (N/L) and the platelet-to-lymphocyte (P/L) ratios, were offered as markers of inflammation in cardiac diseases, neoplasms and diabetes-related complications . Moreover, high leucocyte counts have been used as diagnostic and prognostic markers in vascular complication of diabetes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Evaluate PLR and NLR and their assiotation to vascular complications and glycemic control in type 2 DM', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes mellitus (T2DM) patients with good glycemic control and have HBA1C \\<7and ages ranging from ≥18 old. And poor glycemic control and have HBA1C ≥7 and ages rang from ≥ 18 years old\n\nExclusion Criteria:\n\n* Patients with, type 1 diabetes mellitus\n\n 1. Idiopathic thrombocytopenic purpura,\n 2. liver cell failure\n 3. Myeloproliferative neoplasm\n 4. patients on anticoagulant drugs , anti platelet drugs or on steroids were excluded from the study'}, 'identificationModule': {'nctId': 'NCT06073756', 'briefTitle': 'Neutrophil-lymphocyte and Platelet-lymphocyte Ratios and Their Relations to Vascular Comlications and Glycemic Control in Patients With Type 2 Diabetes Attending The Diabetes Center of Assiut University Hospitals', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Neutrophil-lymphocyte and Platelet-lymphocyte Ratios and Their Relations to Vascular Comlications and Glycemic Control in Patients With Type 2 Diabetes Attending The Diabetes Center of Assiut University Hospitals', 'orgStudyIdInfo': {'id': 'NLR and PLR and in type 2 DM'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Type 2 diabetes mellitus (T2DM) patients with good glycemic control and have HBA1C \\<7and ages ranging from ≥18 old.', 'interventionNames': ['Radiation: Echocardiogram']}, {'label': '2', 'description': 'Type 2 diabetes mellitus (T2DM) patients with poor glycemic control and have HBA1C ≥7 and ages rang from ≥ 18 years old', 'interventionNames': ['Radiation: Echocardiogram']}], 'interventions': [{'name': 'Echocardiogram', 'type': 'RADIATION', 'otherNames': ['ALB / cr ratio', 'Fundus examination', 'ECG', 'Doppler on lower limbs', 'Nerve conduction', 'Echo'], 'description': 'Evaluate PLR and NLR and their assiotation to vascular complications and glycemic control in type 2 DM', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ammar Ashraf Fathy', 'role': 'CONTACT', 'email': 'ammarashraf154@gmail.com', 'phone': '01028177808'}, {'name': 'Salah abdelazem Argoon', 'role': 'CONTACT', 'email': 'argoons@yahoo.com', 'phone': '01019683366'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ammar Ashraf', 'investigatorFullName': 'Ammar Ashraf fathy', 'investigatorAffiliation': 'Assiut University'}}}}