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

Epidemiology and biology of the metabolic syndrome in survivors of childhood cancer.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON24954

Enrollment

1200

Registered

2011-03-16

Start date

2009-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Engels: Childhood cancer survivors Metabolic syndrome Cardiovascular risk factors Adrenal function Physical activity Nederlands: Overlevenden van kinderkanker Metabool syndroom Cardiovasculaire risicofactoren Bijnierfunctie Lichamelijke activiteit

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Patients: 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 criteria

Exclusion criteria: Patients: (Partly) Treated in other country; Controls: A history of childhood cancer.

Design outcomes

Primary

Measure	Time frame
METABOLIC 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 = 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.	—

Measure

Time frame

METABOLIC 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 = 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

Measure	Time frame
ADRENAL 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.	—

Measure

Time frame

ADRENAL 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.

—

Contacts

Public ContactM.M. Heuvel-Eibrink, van den

Erasmus Medical Center, Sophia Children's Hospital, Department of Oncology/Hematology, P.O. Box 2060

m.vandenheuvel@erasmus.nl

Outcome results