Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-02-09 @ 7:40 AM
Study NCT ID:
NCT06349850
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Value of Serum Uric Acid to HDL Cholesterol Ratio for Diabetic Kidney Injury in Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-07-29', 'releaseDate': '2025-07-15'}], 'estimatedResultsFirstSubmitDate': '2025-07-15'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-13', 'studyFirstSubmitDate': '2024-03-31', 'studyFirstSubmitQcDate': '2024-03-31', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uric acid to HDL-c ratio (UHR)', 'timeFrame': '6 months', 'description': 'asociation of high UHR with development of DKI in type 2 DM'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DKI'], 'conditions': ['Diabetic Kidney Injury']}, 'referencesModule': {'references': [{'pmid': '29990996', 'type': 'BACKGROUND', 'citation': 'Evans K, Pyart R, Steenkamp R, Whitlock T, Stannard C, Gair R, McCann J, Slevin J, Medcalf J, Caskey F. UK Renal Registry 20th Annual Report: Introduction. Nephron. 2018;139 Suppl 1:1-12. doi: 10.1159/000490958. Epub 2018 Jul 10. No abstract available.'}, {'pmid': '28164387', 'type': 'BACKGROUND', 'citation': 'Koye DN, Shaw JE, Reid CM, Atkins RC, Reutens AT, Magliano DJ. Incidence of chronic kidney disease among people with diabetes: a systematic review of observational studies. Diabet Med. 2017 Jul;34(7):887-901. doi: 10.1111/dme.13324. Epub 2017 Mar 9.'}, {'pmid': '31518657', 'type': 'BACKGROUND', 'citation': 'Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.'}, {'pmid': '23067652', 'type': 'BACKGROUND', 'citation': 'National Kidney Foundation. KDOQI Clinical Practice Guideline for Diabetes and CKD: 2012 Update. Am J Kidney Dis. 2012 Nov;60(5):850-86. doi: 10.1053/j.ajkd.2012.07.005.'}]}, 'descriptionModule': {'briefSummary': 'An prospective observetional study to asses the predictive value of serum uric acid to high density lipoprotein cholesterol ratio for diabetic kidney injury in type 2 diabetes', 'detailedDescription': 'Diabetic Kidney Injury (DKI) is a serious microvascular complication of diabetes mellitus occuring in about 20 % to 50% of diabetic patients and is the single commonest cause of ESRD.DKI is asociated with arterial HTN and increased cardiovascular morbidity and mortality. outcomes for both type 1 DM and type 2 DM who develop DKI are significantly worse than who do not .Serum uric acid was reported to be asociated with inflamatory and metabolic diseases such as metabolic syndrome , type 2 DM,thyroiditis and NAFLD while HDL-cholesterol decreased the odds of developing DKI by 20%.It is generally accepted that hyperuricemia and low HDL-c were considered to be a risk factor of other indicators for development of DKI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'we will prospectively enroll patients from internal medicine department from march 2024 to august 2024 .all patients will be subjected to\n\n1. Detailed medical history including : demographic characteristics,comorbid conditions,duration of diabetes mellitus,type of treatment and diabetic complications\n2. Detailed clinical examination including : height , weight ,waist circumferenc,SBP,DBP,BMI\n3. Fundus examination for retinopathy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetic patients\n* willing and agreed to be included in the study\n\nExclusion Criteria:\n\n* Type 1 DM patients\n* patients with active urinary sediment\n* patients with glomerulonephritis\n* patients with diagnosis or clinical features that are suspicious for another systemic disease that commonly causes kidney disease\n* patients with evidence of alternative kidney disease\n* patients with history of kidney transplantation\n* patients with end stage renal disease\n* patients with family history of non diabetic forms of kidney disease\n* patients with active malignancy\n* patients with established hemolytic disease\n* CKD patients requiring dialysis\n* patients taking drugs that interfere with serum uric acid level\n* patients taking drugs that alter serum lipids level\n* pregnancy\n* Refused to consent to this study'}, 'identificationModule': {'nctId': 'NCT06349850', 'briefTitle': 'Predictive Value of Serum Uric Acid to HDL Cholesterol Ratio for Diabetic Kidney Injury in Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Predictive Value of Serum Uric Acid to High Density Lipoprotein Cholesterol Ratio for Diabetic Kidney Injury in Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'Soh-Med-24-03-06MS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HbA1c level group', 'description': '* well controlled diabetic group : HBA1c less than 7%\n* poorly controlled diabetic group : HBA1c equal to ore more than 7%', 'interventionNames': ['Diagnostic Test: serum uric acid level to plasma HDL-c level ratio (UHR)']}, {'label': 'UHR level group', 'description': 'median levels of UHR will be used to dichotomize the patients into groups of :\n\n* low UHR group\n* high UHR group', 'interventionNames': ['Diagnostic Test: serum uric acid level to plasma HDL-c level ratio (UHR)']}, {'label': 'DKI group', 'description': 'study population will be grouped into another two groups according to the presence of DKI:\n\n* patients with DKI\n* patients without DKI', 'interventionNames': ['Diagnostic Test: serum uric acid level to plasma HDL-c level ratio (UHR)']}], 'interventions': [{'name': 'serum uric acid level to plasma HDL-c level ratio (UHR)', 'type': 'DIAGNOSTIC_TEST', 'description': 'high UHR is considered to be a risk factor for development of DKI in type 2 DM', 'armGroupLabels': ['DKI group', 'HbA1c level group', 'UHR level group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Eldeeb E. Mohamed, Resident', 'role': 'CONTACT', 'email': 'deebbayern13@gmail.com', 'phone': '01092700322'}, {'name': 'Ali T. Ali, Professor', 'role': 'CONTACT', 'phone': '01005871047'}], 'overallOfficials': [{'name': 'Eldeeb E. Mohamed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sohag University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Eldeeb Elsayed Mohamed', 'investigatorFullName': 'Eldeeb Elsayed Mohamed', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-07-15', 'type': 'RELEASE'}, {'date': '2025-07-29', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Eldeeb Elsayed Mohamed, Eldeeb Elsayed Mohamed, Sohag University'}}}}