Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT07266220
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Carotid Doppler Screening for Subclinical Atherosclerosis in Diabetic CKD Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-11-22', 'studyFirstSubmitQcDate': '2025-12-03', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of subclinical carotid atherosclerosis (defined as increased carotid intima-media thickness and/or carotid plaque detected by carotid Doppler ultrasound).', 'timeFrame': 'At baseline (single assessment at enrollment).', 'description': 'Carotid Doppler ultrasound will be performed once at study entry to measure carotid intima-media thickness and detect the presence of carotid plaque. The percentage of patients with subclinical carotid atherosclerosis will be estimated among adults with type 2 diabetes mellitus and stage 3 chronic kidney disease.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2', 'Chronic Kidney Disease', 'Atherosclerosis']}, 'descriptionModule': {'briefSummary': 'This study is being done at Assiut University to look for early signs of hardening of the arteries (atherosclerosis) in people who have both diabetes and chronic kidney disease (CKD). Many patients with these conditions are at higher risk of heart disease and stroke, but the disease can develop quietly without symptoms.\n\nWe will use a safe, non-invasive test called carotid Doppler ultrasound, which uses sound waves to check the neck arteries (carotid arteries) for early changes. The goal is to see how often these early changes occur in patients with diabetes and CKD, and whether the findings relate to their kidney function, blood sugar control, and other health factors.\n\nThis research may help doctors detect vascular problems earlier and guide better prevention strategies for patients at risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with type 2 diabetes mellitus and stage 3 chronic kidney disease recruited from the nephrology and internal medicine outpatient clinics and inpatient wards of Assiut University Hospitals.', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Age≥18years.\n2. Diagnosis of type 2 diabetes mellitus (per treating physician or ADA criteria).\n3. CKDstage3:eGFR30-59mL/min/1.73 m² on at least two measurements ≥3 months apart OR established diagnosis in medical record.\n4. Clinically stable (no AKI, no hospitalization for cardiovascular event in past 3 months).\n5. Ableandwilling to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT07266220', 'acronym': 'DiCKD-CAROTID', 'briefTitle': 'Carotid Doppler Screening for Subclinical Atherosclerosis in Diabetic CKD Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Screening for Subclinical Atherosclerosis in Diabetic CKD Using Carotid Doppler', 'orgStudyIdInfo': {'id': 'AUN-IM-CKD-CAROTID-2025'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abdallah Ali Mohammed', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Resident Physician, Internal Medicine', 'investigatorFullName': 'Abdallah Ali Mohammed', 'investigatorAffiliation': 'Assiut University'}}}}