Clinical trial

Danish Precocious Puberty Study (DAPP Study) A National Cohort Study on Incidence and Etiologies for Precocious Puberty

Name
DanishPrecociousPubertyStudy
Description
There is an urgent need to obtain more knowledge about the influence of weight and metabolism on the timing and progression of puberty. The age of pubertal onset has been constantly declining during the last decades and extremely early maturation may have yet unseen consequences for the psychosocial development of the child as well as detrimental long-term health consequences. Studies have shown that girls with early-onset puberty are more likely than their peers to enter sexual relationships at a younger age, to experience more psychological distress, and to engage in risk-taking behaviors. In addition, early maturation may have long-term health consequences since earlier menarche is associated with an increased risk of all-cause mortality and cardiovascular disease later in life in large epidemiological studies. The exact aetiology for the earlier onset of puberty in the general population remains to be elucidated, and the cause is probably to be found in a complex interplay between genetic, epigenetic, environmental and metabolic factors. However, world-wide there is a concerning increasing prevalence of overweight in childhood and early puberty is one of many consequences of this. Environmental factors such as endocrine disrupting chemicals have been suggested to play a role for both obesity and precocious puberty either directly or through epigenetic moderation. The current study of a Danish National cohort will explore the incidence and aetiology of precocious puberty for better treatment and prevention. Furthermore, a placebo-controlled randomized controlled trial may give a novel mechanistic insight of the interplay between insulin sensitivity and sex steroids. To our knowledge this study is the first of its kind and may lead to novel alternative treatment strategy for overweight girls with early puberty that may have beneficial effects on long-term morbidity and mortality.
Trial arms
Trial start
2023-09-01
Estimated PCD
2026-08-30
Trial end
2030-09-01
Status
Not yet recruiting
Treatment
Metformin Hydrochloride tablet
Treatment with metformin
Arms:
Met + lifestyle intervention, Met -lifestyle intervention
Other names:
Metformin
Placebo
Treatment with placebo
Arms:
Placebo+lifestyle intervention, Placebo-lifestyle intervention
Lifestyle intervention
Changing behaviour on diet and excersise
Arms:
Met + lifestyle intervention, Placebo+lifestyle intervention
No lifestyle intervention
No changes in behaviou on diet and excersise
Arms:
Met -lifestyle intervention, Placebo-lifestyle intervention
Size
1500
Primary endpoint
Incidence of CPP among all children referred to 18 Danish pediatric departments during a 3-year period
3 years
BMI (SDS) at pubertal onset
3 years
Genome-wide methylation patterns in peripheral blood associated with CPP and treatment
3 years
Urinary EDC excretion profiles in CPP children compared to age-matched controls
3 years
Randomised placebo controlled trial
3 years
Eligibility criteria
Inclusion Criteria: • All children (\> 4 years of age) referred to one of the seventeen collaborating pediatric departments with one of the following diagnosis (ICD10) * DE301 * DE228A * DE308A * DE270B * DE308 * DE309 * DZ003 Exclusion Criteria: * If the investigating doctor at the local hospital observes unexpected psychological/physical reactions, or a participant is found to be unsuitable (cf. inclusion criteria) or regrets agreeing to participate, this person can at any given time be excluded.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '2 Years', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood sample for hormone analysis, genetic and epigenetic analysis Urine sample analysis of endocrine disrupting chemicals'}, 'enrollmentInfo': {'count': 1500, 'type': 'ESTIMATED'}}
Updated at
2023-07-24

1 organization

1 product

1 drug

2 indications

Product
Metformin
Indication
Adolescence
Indication
Precocious