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Trial record 5 of 234 for:    puberty

Long-term Outcome of GnRH Analogues Treatment of Children With Idiopathic Central Precocious Puberty

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ClinicalTrials.gov Identifier: NCT02790112
Recruitment Status : Enrolling by invitation
First Posted : June 3, 2016
Last Update Posted : June 3, 2016
Sponsor:
Collaborator:
Belgian Study Group for Pediatric Endocrinology
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary:
This study evaluates the influence of early adiposity rebound, genetic polymorphisms and GnRHa treatment on long-term outcome of girls with idiopathic central precocious puberty.

Condition or disease Intervention/treatment Phase
Puberty, Precocious Adiposity Other: GnRHas Not Applicable

Detailed Description:
Gonadotropin-releasing hormone (GnRH) analogs are the mainstay of treatment for central precocious puberty (CPP) since 1985. The relatively short time period elapsed since the introduction of this therapy has not allowed until now to carry out exhaustive studies on the long-term evolution of treated patients. This project will analyze the long-term outcomes of patients with CPP treated or not with GnRHas on adult height, body mass index, body composition, metabolic disorders, bone mineralization, gonadal function, and fertility in comparison to a control group. Overweight before puberty is associated to earlier menarche, and conversely, earlier menarche predispose to adult obesity and metabolic disorders. Nevertheless, it is unclear if adult adiposity is a direct consequence of early puberty or if early puberty is a marker of a predisposition to excess adiposity from prepuberty through adult life. Recent data in rodent models support the hypothesis that early nutritional status determines a risk for both childhood and adult obesity and influences pubertal timing. In girls, early weight gain in childhood has been associated with early menarche. Pattern of growth rather than absolute level of fatness seem to be of most importance. So the first aim of this study is to compare the outcomes of CCP patients with or without an early adiposity rebound and to demonstrate that adiposity rebound more than CPP per se or the GnRHas therapy affect the outcomes. Moreover, recent genome-wide association studies have identified obesity-related gene variants associated with earlier age at menarche. The investigators hypothesized that there might be a genetic basis underlying the early programming of both childhood and adulthood adiposity and puberty timing. The investigators thus aim to determine if those obesity-related gene variants associated with an early but not precocious menarche could also be found in CPP, especially in girls with an early adiposity rebound and if their presence may affect adult health.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 418 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Early Adiposity Rebound, Genetic Polymorphisms and GnRHa Treatment on Long-term Outcome of Girls With Idiopathic Central Precocious Puberty.
Study Start Date : April 2016
Actual Primary Completion Date : April 2016
Estimated Study Completion Date : October 2018


Arm Intervention/treatment
GnRHas - Not GnRHas patients
Compared long term outcome of treated and untreated patients with idiopathic central precocious puberty : hormonal assessment; DNA for candidate single nucleotide polymorphisms (SNP) analyses; pelvic ultrasound; dual energy x-ray absorptiometry (DXA)
Other: GnRHas

Influence of early adiposity rebound, genetic polymorphisms and GnRHa treatment on long-term outcome of treated and untreated girls with idiopathic central precocious compared to a control group.

puberty.

GnRHas - controls patients
Compared long term outcome of treated patients with idiopathic central precocious puberty and control patients for: hormonal assessment; DNA for candidate single nucleotide polymorphisms (SNP) analyses; pelvic ultrasound; dual energy x-ray absorptiometry (DXA)
Other: GnRHas

Influence of early adiposity rebound, genetic polymorphisms and GnRHa treatment on long-term outcome of treated and untreated girls with idiopathic central precocious compared to a control group.

puberty.

Not GnRHas - Controls patients
Compared long term outcome of untreated patients with idiopathic central precocious puberty and control patients for: hormonal assessment; DNA for candidate single nucleotide polymorphisms (SNP) analyses; pelvic ultrasound; dual energy x-ray absorptiometry (DXA)
Other: GnRHas

Influence of early adiposity rebound, genetic polymorphisms and GnRHa treatment on long-term outcome of treated and untreated girls with idiopathic central precocious compared to a control group.

puberty.




Primary Outcome Measures :
  1. Single nucleotide polymorphisms (SNP) analyses [ Time Frame: 1 day ]
    DNA analyses


Secondary Outcome Measures :
  1. Adult height in meters [ Time Frame: 1 day ]
    Measured at consultation

  2. Body mass index in kg/m2 [ Time Frame: 1 day ]
    Calculated at consultation

  3. Body composition in % [ Time Frame: 1 day ]
    Dual energy x-ray absorptiometry (DXA): fat (visceral) and lean mass.

  4. Glucose in mg/dl [ Time Frame: 1 day ]
    Fasting blood sampling

  5. Total Cholesterol in mg/dl [ Time Frame: 1 day ]
    Fasting blood sampling

  6. LDL-Cholesterol in mg/dl [ Time Frame: 1 day ]
    Metabolic assessment (fasting blood sampling)

  7. HDL-Cholesterol in mg/dl [ Time Frame: 1 day ]
    Fasting blood sampling

  8. Insulin in microU/ml [ Time Frame: 1 day ]
    Fasting blood sampling

  9. Total bone mineralization in Tscore [ Time Frame: 1 day ]
    Dual energy x-ray absorptiometry (DXA):

  10. Lumbar bone mineralization in Tscore [ Time Frame: 1 day ]
    Dual energy x-ray absorptiometry (DXA):

  11. Femoral neck bone mineralization in Tscore [ Time Frame: 1 day ]
    Dual energy x-ray absorptiometry (DXA):

  12. Ovaries volume in ml [ Time Frame: 1 day ]
    Pelvic ultrasound (at 2nd-5th day of the menstrual cycle)

  13. Ovaries follicles diameter in mm [ Time Frame: 1 day ]
    Pelvic ultrasound (at 2nd-5th day of the menstrual cycle)

  14. Chronic anovulation in number [ Time Frame: 1 day ]
    Number of mentruals cycles in a year

  15. SHBG by nmol/l [ Time Frame: 1 day ]
    Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea)

  16. Total serum testosterone by ng/dl [ Time Frame: 1 day ]
    Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea)

  17. Ovaries follicles counting [ Time Frame: 1 day ]
    Pelvic ultrasound (at 2nd-5th day of the menstrual cycle)

  18. Abdominal perimeter in cm [ Time Frame: 1 day ]
    Measured at consultation

  19. Hip perimeter in cm [ Time Frame: 1 day ]
    Measured at consultation

  20. Blood pressure in mmHg [ Time Frame: 1 day ]
    Measured at consultation

  21. Testicular volume in ml [ Time Frame: 1 day ]
    Measured at consultation

  22. LH in IU/L [ Time Frame: 1 day ]
    Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea)

  23. FSH in IU/L [ Time Frame: 1 day ]
    Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea)

  24. Oestradiol in ng/dl [ Time Frame: 1 day ]
    Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea)

  25. DHEAS in micromol/l [ Time Frame: 1 day ]
    Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea)

  26. 17 hydroxyprogesterone in ng/ml [ Time Frame: 1 day ]
    Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea)

  27. Anti-Müllerian Hormone in ng/ml [ Time Frame: 1 day ]
    Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea)

  28. Inhibine in pg/ml [ Time Frame: 1 day ]
    Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea)

  29. Prolactine in microgr/L [ Time Frame: 1 day ]
    Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea)

  30. Uterine diameter in mm [ Time Frame: 1 day ]
    Pelvic ultrasound (at 2nd-5th day of the menstrual cycle)

  31. Uterine volume in ml [ Time Frame: 1 day ]
    Pelvic ultrasound (at 2nd-5th day of the menstrual cycle)

  32. Endometrius thickness in mm [ Time Frame: 1 day ]
    Pelvic ultrasound (at 2nd-5th day of the menstrual cycle)


Other Outcome Measures:
  1. Quality of life [ Time Frame: 1 day ]
    Self-perception profile for adults, Messer & Harter 2012



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • History of idiopathic CPP (ICPP) treated with GnRHas.
  • A diagnosis of CPP made according to the following criteria: 1) secondary pubertal signs (Tanner stage 2) before 8 years in girls and 9 years in boys; 2) accelerated growth velocity (GV); 3) BA advanced for CA ≥ 1 year; 4) GnRH-stimulated peak LH >5 IU/L.
  • A diagnosis of idiopathic CPP according the following criteria: 1) no hypothalamic-pituitary organic lesions at magnetic resonance imaging; 2) no known medical condition that might affect the onset of puberty.
  • To determine whether the supposed long-term effects of treatment are instead consequences of the disease itself, untreated ICPP girls aged of ≥ 18 years, will also be included. For comparative purposes, age-matched normal (menarche > 10 y) volunteers will be recruited as a control group.

Exclusion Criteria:

  • In the treated ICCP group if 1) treatment with GnRHas for < 2 years; 2) non-compliance; 3) no gonadotropin suppression observed.
  • For all patients: 4) small for gestational age; 5) chronic disease and/or treatment; 6) being < 4 years from menarche.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790112


Locations
Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Belgian Study Group for Pediatric Endocrinology
Investigators
Principal Investigator: Constanza Navarro Moreno, D Cliniques universitaires Saint-Luc

Publications:

Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT02790112     History of Changes
Other Study ID Numbers: 2015/14OCT/549
RESEARCH GRANT ( Other Grant/Funding Number: BELGIAN STUDY GROUP FOR PEDIATRIC ENDOCRINOLOGY VZW/ASBL )
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for some outcome measures will be made available within 6 months of study recruitment for the Belgian Study Group for Pediatric Endocrinology.

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Body Mass Index
Body Composition
Glucose Metabolism Disorders
Bone Development
Gonadal Disorders
Fertility
Overweight
Obesity
Menarche

Additional relevant MeSH terms:
Obesity
Puberty, Precocious
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Gonadal Disorders
Endocrine System Diseases