Danish Precocious Puberty Study - DAPP Study A National Cohort Study on Incidence and Etiologies for Precocious Puberty
DAPP
1 other identifier
observational
1,500
1 country
5
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2023
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2023
CompletedFirst Posted
Study publicly available on registry
July 24, 2023
CompletedStudy Start
First participant enrolled
September 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2030
July 24, 2023
July 1, 2023
3 years
July 14, 2023
July 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Incidence of CPP among all children referred to 18 Danish pediatric departments during a 3-year period
Number of patients referred who have precocious puberty
3 years
BMI (SDS) at pubertal onset
Adiposity in children with precocious puberty
3 years
Genome-wide methylation patterns in peripheral blood associated with CPP and treatment
epigenetic alterations
3 years
Urinary EDC excretion profiles in CPP children compared to age-matched controls
endocrine disrupting chemicals associated to early puberty
3 years
Randomised placebo controlled trial
The effect of metformin and/or lifestyle intervention on pubertal development
3 years
Study Arms (4)
Met -lifestyle intervention
Girls with overweight and early puberty aged 8-9 years Treatment with metformin without lifestyle intervention (diet, training)
Met + lifestyle intervention
Girls with overweight and early puberty aged 8-9 years Treatment with metformin with lifestyle intervention (diet, training)
Placebo-lifestyle intervention
Girls with overweight and early puberty aged 8-9 years Treatment with placebo without lifestyle intervention (diet, training)
Placebo+lifestyle intervention
Girls with overweight and early puberty aged 8-9 years Treatment with placebo with lifestyle intervention (diet, training)
Interventions
Treatment with metformin
Changing behaviour on diet and excersise
No changes in behaviou on diet and excersise
Eligibility Criteria
Seventeen pediatric hospital departments in Denmark will be included and an expected more than 1,500 children referred for early puberty will be invited to participate in the study. Since this cohort consists of patients who are going through the examinations and blood samples as part of the routine clinical work-up for CPP we expect a high participation rate around 70-80%. The patients are asked for a fasting blood sample and a urine sample for the clinical biobank. It is essential to include all departments to evaluate the incidence of precocious puberty in Denmark and to ensure power for the analyses of etiology.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Copenhagen University Hospital - Herlev
Herlev, Capital Region, 2730, Denmark
Univerity Hospital Aalborg
Aalborg, Denmark
University Hospital Aarhus
Aarhus, Denmark
University Hospital Odense
Odense, Denmark
University Hospital Roskilde
Roskilde, Denmark
Biospecimen
Blood sample for hormone analysis, genetic and epigenetic analysis Urine sample analysis of endocrine disrupting chemicals
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor PhD
Study Record Dates
First Submitted
July 14, 2023
First Posted
July 24, 2023
Study Start
September 1, 2023
Primary Completion (Estimated)
August 30, 2026
Study Completion (Estimated)
September 1, 2030
Last Updated
July 24, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data requests may be submitted from 12 to 24 months after publication of the article.
- Access Criteria
- Access to trial IPD can be requested by qualified researchers engaging in scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)
Data collected in the study may be provided to qualified researchers with academic interest in precocious puberty. Shared data will be coded, with no protected health information included. Approval of the request are prerequisites to the sharing of data with the requesting party. Access to trial IPD can be requested by qualified researchers engaging in scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)