Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-03-09 @ 4:06 AM
Study NCT ID:
NCT05061459
Status:
UNKNOWN
Last Update Posted:
2021-09-29
First Post:
2021-09-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Expression of circANKRD36 as a New Biomarker of Diabetic Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-28', 'studyFirstSubmitDate': '2021-09-20', 'studyFirstSubmitQcDate': '2021-09-28', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Expression levels of circANKRD36 in the development and progression of DN.', 'timeFrame': 'baseline', 'description': 'circANKRD36 by reverse transcription-quantitative polymerase chain reaction (RT-qPCR)'}], 'secondaryOutcomes': [{'measure': 'Correlation between expression levels of circANKRD36 and pro-inflammatory cytokine (TNF-α and IL-6) in the development and progression of DN.', 'timeFrame': 'baseline', 'description': 'pro-inflammatory cytokine TNF-α by enzyme-linked immunosorbent assay (ELISA). IL-6 by Chemiluminescence on Advia centaur XPT.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Nephropathy']}, 'descriptionModule': {'briefSummary': '1. To evaluate expression levels of circANKRD36 in the development and progression of DN.\n2. To investigate correlation between expression levels of circANKRD36 and stages of DN.\n3. To investigate correlation between expression levels of circANKRD36 and pro-inflammatory cytokine (TNF-α and IL-6) in T2DM patients with CKD.', 'detailedDescription': "Type 2 Diabetes Mellitus (T2DM) is one of the most common metabolic disorders that's become a global health burden affecting 463 million people worldwide according to the International Diabetes Federation (IDF). Diabetic nephropathy(DN) is one of the most common secondary complications of DM and is becoming a major cause of morbidity and mortality among diabetic patients . DN is a microvascular complication occurring in approximately 20-40% of patients with T2DM . DN has been described as a glomerular disorder with the following phases: glomerular hyperfiltration, incipient nephropathy, microalbuminuria, overt proteinuria and end-stage renal disorder. Microalbuminuria is the gold standard for the early diagnosis of DN. However, many studies have suggested that it is inadequate and has some drawbacks. Recent novel biomarkers have been accepted for early diagnosis and progression of DN in patients with T2DM . Renal cells are capable of synthesizing pro-inflammatory cytokines such as tumor necrotic factor-alpha (TNF-α), interleukin-1β (IL-1β) and interleukin-6 (IL-6), these cytokines acting in a paracrine or autocrine manner that leading to the development and progression of several renal disorders .Circular RNAs are class of endogenous non coding RNAs and are associated with numerous diseases like T2DM. Circular ankyrin repeat domain 36 (circANKRD36) involved in T2DM and inflammation-associated pathways via interaction with miRNAs, including hsa-miR-3614-3p, hsa-miR-498, and hsa-miR-501-5p. The expression of circANKRD36 was upregulated in peripheral blood leucocytes and was correlated with chronic inflammation in T2DM. Therefore, circANKRD36 can be used as a potential biomarker for screening chronic inflammation in patients with T2DM."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include 96 (68 patients diagnosed as T2DM and 28 apparently healthy subjects as control group).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed as Type 2 Diabetes Mellitus\n\nExclusion Criteria:\n\n* Any other clinically systemic acute or chronic inflammation disease/s.\n* Autoimmune disease.\n* Any endocrine disease other than T2DM.\n* Cancer.\n* Chronic hepatic or renal failure.'}, 'identificationModule': {'nctId': 'NCT05061459', 'briefTitle': 'The Expression of circANKRD36 as a New Biomarker of Diabetic Nephropathy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Expression of circANKRD36 as a New Biomarker of Diabetic Nephropathy in Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'The expression of circANKRD36'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group1:', 'description': '28 control', 'interventionNames': ['Genetic: circANKRD36 as a new biomarker']}, {'label': 'Group 2:', 'description': '68 T2DM patients', 'interventionNames': ['Genetic: circANKRD36 as a new biomarker']}], 'interventions': [{'name': 'circANKRD36 as a new biomarker', 'type': 'GENETIC', 'description': 'expression levels of circANKRD36 in the development and progression of DN', 'armGroupLabels': ['Group 2:', 'Group1:']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marwa Magdy Hamed Mohamed, Assistant lecturer', 'role': 'CONTACT', 'email': 'marwamagdy@med.aun.edu.eg', 'phone': '01005745012'}, {'name': 'Heba Ahmed Abdel Hafeez, Prof. Dr.', 'role': 'CONTACT', 'email': 'dr_heba.ahmed@yahoo.com', 'phone': '01006268407'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Marwa Magdy Hamed Mohamed', 'investigatorAffiliation': 'Assiut University'}}}}