Cardiovascular Risk Factors After Renal Transplantation in Children and Adults (HENT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Oslo University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Norwegian Red Cross
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01008306
First received: November 3, 2009
Last updated: November 4, 2009
Last verified: November 2009
  Purpose

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.

Focus 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.


Condition
Exercise Capacity
Physical Activity
Hypertension
Overweight and Obesity
Metabolic Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Outcome After Pediatric Renal Transplantation: Cardiorespiratory Fitness, Cardiovascular Risk Factors and Quality of Life

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Secondary Outcome Measures:
  • other cardiovascular risk factors [ Time Frame: 2007-2010 ] [ Designated as safety issue: No ]
  • hypertension [ Time Frame: 2007-2010 ] [ Designated as safety issue: No ]
  • impaired glucose intolerance [ Time Frame: 2007-2010 ] [ Designated as safety issue: No ]
  • left ventricular hypertrophy, [ Time Frame: 2007-2010 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Freezing of serum and plasma from study participants


Estimated Enrollment: 60
Study Start Date: June 2007
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Renal transplanted children and young adults

Renal transplanted children and adolescents (2-18yrs) transplanted between 1993-2006.

Renal transplanted young adults aged 20-35 yrs old, transplanted from 1983 onwards.


  Eligibility

Ages Eligible for Study:   2 Years to 38 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Renal transplanted children, adolescents and young adults transplanted in the period 1983-2006 in the same center (Oslo University Hospital, Rikshospitalet)

Criteria

Inclusion Criteria:

  • Transplanted after 1983, functioning graft

Exclusion Criteria:

  • Patients in dialysis
  • In part of the study concerning treadmill testing: Age<8 years, orthopedic limitations
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01008306

Locations
Norway
Oslo University Hospital Rikshospitalet HF, Division of Pediatrics
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
Norwegian Red Cross
  More Information

No publications provided

Responsible Party: Oslo University Hospital, Rikshospitalet HF, Rikshospitalet HF, department of pediatrics
ClinicalTrials.gov Identifier: NCT01008306     History of Changes
Other Study ID Numbers: S-07245b
Study First Received: November 3, 2009
Last Updated: November 4, 2009
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Cardiorespiratory fitness
physical activity
hypertension
overweight and obesity
metabolic syndrome
Body composition

Additional relevant MeSH terms:
Hypertension
Obesity
Overweight
Metabolic Syndrome X
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 28, 2014