E66.04
Conditions
Interventions
Group 1: Cohort I (“Reference cohort”): recruitment of 100 healthy children/adolescents (50 male/ 50 female participants) without altered pubertal development (age range: 1-18 years).
Group 2: Cohort
premature thelarche, precocious adrenarche (age: boys younger than 9 years, females younger than 8 years) and delayed central puberty (age: boys older than 14 years, females older than 13 years)
(sum n=120) will be recruited.
Group 3: Cohort III (“Obesity cohort”): 200 male and 200 female individuals with obesity will be recruited (BMI above 95. percentile
age: 8-18 years).
Group 4: Cohort IV: patients with rare endocrine diseases (e.g. congenital adrenal hyperplasia, genetic disturbances of hypothalamic hormone production and -action)
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Female or male 2. Aged between 1 month and 18 years 3. Cohort 1 (‘reference cohort’): no chronic illness 4. Cohort 2 (‘cohort with altered pubertal development’): diagnosis of pubertas praecox or premature pubarche, premature thelarche or pubertas tarda 5. Cohort 3 (‘obesity cohort’): obesity (BMI above the 97th percentile) 6. Cohort 4 children with genetic diseases (e.g. obesity due to POMC deficiency or increased sex hormone production in congenital adrenal hyperplasia)
Exclusion criteria
Exclusion criteria: 1. Ongoing participation in a drug trial, or if participation ended less than one month ago 2. Sleep disorders, periodic leg movements 3. Alcohol, tobacco, drug abuse 4. Flights across at least two time zones within the last four weeks prior to inclusion 5. Acute psychosocial stress situation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Corrected ‘Midsleep on Free-Days’ MSFsc (corrected for sleep behaviour on working days). The MSF value is calculated as the midpoint between the time of falling asleep and the time of waking up (Roenneberg et al, Sleep Medicine Review, 2007). Metabolic parameters of metabolic syndrome are recorded if a blood sample is required for other medical reasons. MSFsc assessment using questionnaires and use of actimeter data | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. MSFsc in children with altered pubertal development, as well as 2. parameters of metabolic syndrome, e.g. R-HOMA index, if blood sampling is necessary for other medical reasons. 3. Status of desynchronisation of the individual chronotype and actual sleep behaviour: social jet lag; chronotype misalignment 4. Sufficiency of drug treatment for rare endocrine diseases (e.g. hydrocortisone therapy for the treatment of people with congenital adrenal hyperplasia (CAH), effects of an intervention for obesity (e.g. weight loss), change in metabolic parameters indicating metabolic syndrome 5. Measurement of molecular parameters (gene expression) for chronotype (BodyTime) from hair, saliva, urine and, if necessary, blood samples | — |
Countries
Germany
Contacts
Public ContactPeter Kühnen
Charité Universitätsmedizin Berlin
Outcome results
None listed