Exercise CapacityHENTNCT01008306
Cardiovascular Risk Factors After Renal Transplantation in Children and Adults
An observational study of Exercise Capacity and Physical Activity, run by Oslo University Hospital at 1 site in Norway.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 2 to 38 years
- Conditions the study is for
- Exercise Capacity, Physical Activity, Hypertension
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2007to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 38 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Renal transplanted children, adolescents and young adults transplanted in the period 1983-2006 in the same center (Oslo University Hospital, Rikshospitalet)
Who may be able to join
- Transplanted after 1983, functioning graft
Who cannot join
- Patients in dialysis
- In part of the study concerning treadmill testing: Age<8 years, orthopedic limitations
Trial locations and contacts
1 site in 1 country.
Norway1 site
Oslo University Hospital Rikshospitalet HF, Division of Pediatrics
Oslo, Oslo, 0027
About this study
Official title: Outcome After Pediatric Renal Transplantation: Cardiorespiratory Fitness, Cardiovascular Risk Factors and Quality of Life
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.
- Conditions
- Exercise Capacity, Physical Activity, Hypertension, Overweight and Obesity, Metabolic Syndrome
- Keywords
- Cardiorespiratory fitness, physical activity, hypertension, overweight and obesity, metabolic syndrome, Body composition
- Medical subject headings
- Motor Activity, Hypertension, Overweight, Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2009 (estimated)
- Study startJun 2007
- Primary completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Exercise CapacityStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Red Cross
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008306
- Sponsor's protocol ID
- S-07245b
- Acronym
- HENT
- Status last verified
- Nov 2009
- First submitted
- 3 Nov 2009
- Last updated
- 5 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 40845701Sitek 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.
PubMed 24287733
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome After Pediatric Renal Transplantation: Cardiorespiratory Fitness, Cardiovascular Risk Factors and Quality of Life
- ClinicalTrials.gov ID
- NCT01008306
- Acronym / sponsor ID
- HENT / S-07245b
- Conditions
- Exercise Capacity, Physical Activity, Hypertension, Overweight and Obesity, Metabolic Syndrome
- Keywords
- Cardiorespiratory fitness, physical activity, hypertension, overweight and obesity, metabolic syndrome, Body composition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Red Cross
- Study start
- Jun 2007
- Primary completion
- Jun 2010 (estimated)
- First posted
- 5 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 2 to 38 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Renal transplanted children, adolescents and young adults transplanted in the period 1983-2006 in the same center (Oslo University Hospital, Rikshospitalet)
Key inclusion criteria (1 listed)
- Transplanted after 1983, functioning graft
Key exclusion criteria (2 listed)
- Patients in dialysis
- In part of the study concerning treadmill testing: Age<8 years, orthopedic limitations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
4 secondary outcomes
other cardiovascular risk factors
Time frame: 2007-2010
hypertension
Time frame: 2007-2010
impaired glucose intolerance
Time frame: 2007-2010
left ventricular hypertrophy,
Time frame: 2007-2010
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2009.
- Derived from this study: PubMed 40845701Sachs-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.
- Derived from this study: PubMed 24287733Sitek 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exercise Capacity and Physical Activity, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01008306, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2009.