Ignite Creation Date:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
Study NCT ID:
NCT01008306
Status:
UNKNOWN
Last Update Posted:
2009-11-05
First Post:
2009-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiovascular Risk Factors After Renal Transplantation in Children and Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Freezing of serum and plasma from study participants'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'lastUpdateSubmitDate': '2009-11-04', 'studyFirstSubmitDate': '2009-11-03', 'studyFirstSubmitQcDate': '2009-11-04', 'lastUpdatePostDateStruct': {'date': '2009-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'secondaryOutcomes': [{'measure': 'other cardiovascular risk factors', 'timeFrame': '2007-2010'}, {'measure': 'hypertension', 'timeFrame': '2007-2010'}, {'measure': 'impaired glucose intolerance', 'timeFrame': '2007-2010'}, {'measure': 'left ventricular hypertrophy,', 'timeFrame': '2007-2010'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiorespiratory fitness', 'physical activity', 'hypertension', 'overweight and obesity', 'metabolic syndrome', 'Body composition'], 'conditions': ['Exercise Capacity', 'Physical Activity', 'Hypertension', 'Overweight and Obesity', 'Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '40845701', 'type': 'DERIVED', 'citation': 'Sachs-Strommen K, Thorsteinsdottir H, Sakhi AK, Thomsen C, Lie A, Bjerre A, Lyche JL. Urinary levels and estimated daily intake of phthalates and phenols in kidney transplanted Norwegian children. Sci Total Environ. 2025 Oct 10;998:180251. doi: 10.1016/j.scitotenv.2025.180251. Epub 2025 Aug 21.'}, {'pmid': '24287733', 'type': 'DERIVED', 'citation': 'Sitek JC, Tangeraas T, Bjerre A, Helsing P. The prevalence of skin disorders in Norwegian paediatric renal transplant recipients. Acta Derm Venereol. 2014 Jul;94(4):421-4. doi: 10.2340/00015555-1741.'}]}, 'descriptionModule': {'briefSummary': 'Renal transplantation of children started in Norway in 1970.Since the beginning, \\>80% of renal transplants are provided from Living Donors(mainly parents), short pre-transplant dialysis time( median 4 months) and 50% of transplantations are performed before dialysis is needed.This gives good premises for graft survival and avoidance of detrimental effects of dialysis. However, renal transplanted children are subjected to an increased cardiovascular morbidity and mortality in adulthood due to consequences of chronic renal failure and immunosuppressive treatment.Cardiovascular death comprises 30-40% of death causes. In this cross-sectional study we evaluate cardiovascular risk factors in childhood- and also in young adults renal transplanted in childhood.\n\nFocus is cardiorespiratory fitness using treadmill testing,24h BP measurements, anthropometrics including waist circumference,echocardiography,intima media thickness of carotids, glucose intolerance test.Participants are also requested to fill out physical activity recalls and Quality of life questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '38 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Renal transplanted children, adolescents and young adults transplanted in the period 1983-2006 in the same center (Oslo University Hospital, Rikshospitalet)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Transplanted after 1983, functioning graft\n\nExclusion Criteria:\n\n* Patients in dialysis\n* In part of the study concerning treadmill testing: Age\\<8 years, orthopedic limitations'}, 'identificationModule': {'nctId': 'NCT01008306', 'acronym': 'HENT', 'briefTitle': 'Cardiovascular Risk Factors After Renal Transplantation in Children and Adults', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Outcome After Pediatric Renal Transplantation: Cardiorespiratory Fitness, Cardiovascular Risk Factors and Quality of Life', 'orgStudyIdInfo': {'id': 'S-07245b'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Renal transplanted children and young adults', 'description': 'Renal transplanted children and adolescents (2-18yrs) transplanted between 1993-2006.\n\nRenal transplanted young adults aged 20-35 yrs old, transplanted from 1983 onwards.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '0027', 'city': 'Oslo', 'state': 'Oslo County', 'country': 'Norway', 'facility': 'Oslo University Hospital Rikshospitalet HF, Division of Pediatrics', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian Red Cross', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Oslo University Hospital, Rikshospitalet HF', 'oldOrganization': 'Rikshospitalet HF, department of pediatrics'}}}}