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Metabolic syndrome in adult long-term survivors of childhood cancer.


- candidate number9246
- NTR NumberNTR2814
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-mrt-2011
- Secondary IDs2009-030 METC Erasmus MC
- Public TitleMetabolic syndrome in adult long-term survivors of childhood cancer.
- Scientific TitleEpidemiology and biology of the metabolic syndrome in survivors of childhood cancer.
- ACRONYM
- hypothesisMetabolic syndrome is more frequent in long-term survivors of childhood cancer compared with healthy controls.
- Healt Condition(s) or Problem(s) studiedMetabolic syndrome, Cardiovascular risk factors, Paediatric oncology patients, Adrenal function, Physical activity
- Inclusion criteriaPatients:
1. ≥ 18 years old at January 1st in the year they will be recruited;
2. History of childhood cancer;
3. ≥5 years after cessation of therapy;
4. Treated at the Erasmus MC-Sophia Children’s Hospital.

Controls:
1. Brother or sister of the patient;
2. Friend or neighbour of the patient, of the same sex and within an age range of 5 years.
- Exclusion criteriaPatients: (Partly) Treated in other country;
Controls: A history of childhood cancer.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-okt-2009
- planned closingdate1-apr-2012
- Target number of participants1200
- InterventionsN/A
- Primary outcomeMETABOLIC SYNDROME:
1. Waist circumference (high in males when >102cm and in females when >88cm);
2. Waist/Hip ratio (high when >0.9);
3. Fasting plasma glucose (high when >=5.6 mmol/l));
4. Triglycerides (high when >=1.7 mmol/l);
5. HDL-cholesterol (high in males when <1.03 and in females when <1.3);
6. Blood pressure (high when >= 130/85).

CARDIOVASCULAR RISK FACTORS:
Imaging studies:
1. Ultrasound of carotids for measurement of intima media thickness;
2. Pulse wave velocity;
3. Ultrasound of abdominal fat (subcutaneous and preperitoneal).
Laboratory investigations:
1. Uric acid;
2. Cystatin C;
3. Lipidspectrum (total cholesterol, LDL, VLDL, HDL, free fatty acids, triglycerides, apolipoprotein A and B);
4. Thrombotic factors (Antithrombine III, Protein C and S, homocysteine, Plasminogen activator inhibitor-1 (PAI1), routine clotting parameters);
5. Pro-inflammatory markers (TNF-α, IL-6, (high sensitivity)-CRP);
6. Endocrine tests (free T4, TSH, cortisole rhythm (from saliva), IGF-1, IGF-BP-3 and BP-1, ACTH, and routine fertility screening (In females: AMH, Inhibin A en B, DHEA. If not on contraceptives: FSH, LH, oestradiol, progesterone, SHBG. In males: Inhibin B, AMH, testosterone, LH, FSH, SHBG);
7. Insulin;
8. Biomarkers for adiposity (leptin, adiponectin, adipokine);
9. Molecular analyses of genetic aberrations associated with risk factors for elevated metabolic syndrome, i.e. (P207L, D9N mutations in the lipoprotein lipase gene) peroxisome proliferative-activated receptor gamma2 (PPARγ2, aldose reductase, ABCG5 and ABCG8, SUR1, Kir 6-2 gene aberrations, Lipin1 SNPs, AMH SNPs;
10. ALAT, ASAT, gamma-GT;
11. Urine analysis: Microalbuminuria and albumin/creatinin ratio.
- Secondary outcomeADRENAL FUNCTION:
Cortisol and precursos (testosterone, DHEA, DHEAs, 17(OH)progesteron, adion) levels during Synacthen-test (ACTH stimulation test): At baseline, 30 minutes later and 60 minutes later.

PHYSICAL ACITVITY:
The five categories of health-related fitness will be investigated using a series of standardised and validated tests:
Category 1: Cardiopulmonary fitness:
The six-minute walk test, a sub-maximal test, will be used to assess cardiopulmonary fitness;
Category 2: Muscle strength and Category 4: Muscle endurance:
These categories will be measured using the following tests: Hand grip, push-ups, dynamic sit-up, back extension and standing high jump;
Category 3: Flexibility:
The following tests will be used to assess flexibility: Reaching upwards, side bending, sit & reach;
Category 5: Body composition.
- TimepointsAll measurements will be performed on one day.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. M.M. Heuvel-Eibrink, van den
- CONTACT for SCIENTIFIC QUERIESDr. M.M. Heuvel-Eibrink, van den
- Sponsor/Initiator Erasmus Medical Center, Sophia Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Kinderoncologie Centrum Rotterdam (KOCR), Kinderen Kankervrij (KiKa)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD16-mrt-2011 - 24-mrt-2011


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