Clinical Trial: Long-term Outcome of GnRH Analogues Treatment of Children With Idiopathic Central Precocious Puberty
Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional
Official Title: Influence of Early Adiposity Rebound, Genetic Polymorphisms and GnRHa Treatment on Long-term Outcome of Girls With Idiopathic Central Precocious Puberty.
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.
Detailed Summary: 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 prese
Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Current Primary Outcome: Single nucleotide polymorphisms (SNP) analyses [ Time Frame: 1 day ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Adult height in meters [ Time Frame: 1 day ]Measured at consultation
- Body mass index in kg/m2 [ Time Frame: 1 day ]Calculated at consultation
- Body composition in % [ Time Frame: 1 day ]Dual energy x-ray absorptiometry (DXA): fat (visceral) and lean mass.
- Glucose in mg/dl [ Time Frame: 1 day ]Fasting blood sampling
- Total Cholesterol in mg/dl [ Time Frame: 1 day ]Fasting blood sampling
- LDL-Cholesterol in mg/dl [ Time Frame: 1 day ]Metabolic assessment (fasting blood sampling)
- HDL-Cholesterol in mg/dl [ Time Frame: 1 day ]Fasting blood sampling
- Insulin in microU/ml [ Time Frame: 1 day ]Fasting blood sampling
- Total bone mineralization in Tscore [ Time Frame: 1 day ]Dual energy x-ray absorptiometry (DXA):
- Lumbar bone mineralization in Tscore [ Time Frame: 1 day ]Dual energy x-ray absorptiometry (DXA):
- Femoral neck bone mineralization in Tscore [ Time Frame: 1 day ]Dual energy x-ray absorptiometry (DXA):
- Ovaries volume in ml [ Time Frame: 1 day ]Pelvic ultrasound (at 2nd-5th day of the menstrual cycle)
- Ovaries follicles diameter in mm [ Time Frame: 1 day ]Pelvic ultrasound (at 2nd-5th day of the menstrual cycle)
- Chronic anovulation in number [ Time Frame: 1 day ]Number of mentruals cycles in a year
- 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)
- 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)
- Ovaries follicles counting [ Time Frame: 1 day ]Pelvic ultrasound (at 2nd-5th day of the menstrual cycle)
- Abdominal perimeter in cm [ Time Frame: 1 day ]Measured at consultation
- Hip perimeter in cm [ Time Frame: 1 day ]Measured at consultation
- Blood pressure in mmHg [ Time Frame: 1 day ]Measured at consultation
- Testicular volume in ml [ Time Frame: 1 day ]Measured at consultation
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- Inhibine in pg/ml [ Time Frame: 1 day ]Metabolic assessment (blood sampling before
Original Secondary Outcome: Same as current
Information By: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Dates:
Date Received: April 25, 2016
Date Started: April 2016
Date Completion: October 2018
Last Updated: May 30, 2016
Last Verified: May 2016
