Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Puberty
  • Puberty, Precocious
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 5 years and 19 years
Gender
Both males and females

Description

Cross-sectional School study: All children will be examined once and the following data will be collected: Clinical medical examination of the child consisting of height measurements (standing- and sitting-height), arm-span, weight, fat fold measurements (biceps, triceps, flank, subscapularis), circ...

Cross-sectional School study: All children will be examined once and the following data will be collected: Clinical medical examination of the child consisting of height measurements (standing- and sitting-height), arm-span, weight, fat fold measurements (biceps, triceps, flank, subscapularis), circumference of waist and hip, waist-hip ratio, blood pressure, body fat composition. Puberty development will be assessed by trained and experienced clinical personal according to Tanner criteria. Girls will be investigated for assessment of breast development stage B1-5 (by palpation), pubic hair staging PH1-5, occurrence of axillary hair (Stage 0-2), menarche (yes / no), sweat (yes/no) and acne (yes/no), and boys, their genitalia development stage G1-5, pubic hair stage PH1-6, occurrence of axillary hair (yes/no), acne (yes/no), sweat (yes/no) and voice break (yes/no). The testicular volume assessed by means of Praders orchidometer. Blood sample (35 ml) for measurement of: a) Hormone levels, peptides and growth factors (FSH, LH, estradiol (total/free), progesterone, estrone/estrone sulphate, SHBG, testosterone (total/free), DHEAS, 17-hydroxyprogestrerone, androstenedione, 11-dinhibin B, AMH, INSL3 (only boys), kisspeptin, ghrelin, leptin, IGF-1, IGFBP-3, IGF-related peptides, eoxycortisol, cortisol, cortisone, RANKL, OPG, fibroblast growth factor 23 (FGF23), TSH, T4, free T4, T3, free T3, HbA1C, calcium ion, alkaline phosphatase, PTH, magnesium, phosphate, 25-OH-vitamin D, osteocalcin, prolactin, insulin and lipids (HDL, LDL, TG, Ip(a), cholesterol and lipoproteins), blood metabolites (e.g. amino acids, biogenic amines, acylcarnitines, lyso-phosphatidylcholines, phosphatidylcholines, sphingomyelins and hexose) and proteins (e.g. cytokines, growth factors, kinases, plasma receptors, proteases, protease inhibitors, plasma hormones and structural proteins)); b) Endocrine disrupters (PCBs, dioxins, parabens and phtalates); and c) DNA and RNA Morning urine sample (100 ml) for measurement of FSH, LH, testosterone, epitestosterone, androsterone,etiocolanolone and endocrine disrupters (PCBs, parabens, pthalates, bisphenol A, UV-filters and triclosan) Self-administered electronic questionnaire collecting information on previous growth, illness, living conditions, lifestyle factors, parents' puberty history and current hight and weight. Biobank Blood and urine samples will be temporary stored during the data collection period until 30th of Jule 2025. After this date, all unused serum, urine and DNA/RNA not used in the planned analyses will be stored at the established permanent (RegionH, Fælles Fryserfaciliteter) biobank (BIOSEK). The period of storage here is 30 years from the date that the temporary storage is closed. Prospective Registry-based Cohort study of the Long-term health and death risk after extremely early puberty: With a follow-up design, we will assess risk of morbidity and mortality amongst cases and referent children. Hazard rations (HRs) will be calculated using Cox regression analyses with stratification using each case and his/her matched referent subjects as a stratum. This ensures that comparisons are adjusted for age and calendar time. Co-variates includes maternal (BMI, smoking, socioeconomic status) during the index pregnancy, also birth weight, length and head circumference of participants. All will be identified in national registries for all persons.

Tracking Information

NCT #
NCT04884620
Collaborators
  • Environmental Protection Agency (EPA)
  • European Commission
Investigators
Principal Investigator: Anders Juul, PhD, DMSc Rigshospitalet, Department of Growth and Reproduction