Adiposity Clinical Trial
Official title:
Influence of Early Adiposity Rebound, Genetic Polymorphisms and GnRHa Treatment on Long-term Outcome of Girls With Idiopathic Central Precocious Puberty.
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.
Status | Enrolling by invitation |
Enrollment | 418 |
Est. completion date | October 2018 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Cliniques Universitaires Saint-Luc | Brussels |
Lead Sponsor | Collaborator |
---|---|
Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Belgian Study Group for Pediatric Endocrinology |
Belgium,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Quality of life | Self-perception profile for adults, Messer & Harter 2012 | 1 day | Yes |
Primary | Single nucleotide polymorphisms (SNP) analyses | DNA analyses | 1 day | Yes |
Secondary | Adult height in meters | Measured at consultation | 1 day | Yes |
Secondary | Body mass index in kg/m2 | Calculated at consultation | 1 day | Yes |
Secondary | Body composition in % | Dual energy x-ray absorptiometry (DXA): fat (visceral) and lean mass. | 1 day | Yes |
Secondary | Glucose in mg/dl | Fasting blood sampling | 1 day | Yes |
Secondary | Total Cholesterol in mg/dl | Fasting blood sampling | 1 day | Yes |
Secondary | LDL-Cholesterol in mg/dl | Metabolic assessment (fasting blood sampling) | 1 day | Yes |
Secondary | HDL-Cholesterol in mg/dl | Fasting blood sampling | 1 day | Yes |
Secondary | Insulin in microU/ml | Fasting blood sampling | 1 day | Yes |
Secondary | Total bone mineralization in Tscore | Dual energy x-ray absorptiometry (DXA): | 1 day | Yes |
Secondary | Lumbar bone mineralization in Tscore | Dual energy x-ray absorptiometry (DXA): | 1 day | Yes |
Secondary | Femoral neck bone mineralization in Tscore | Dual energy x-ray absorptiometry (DXA): | 1 day | Yes |
Secondary | Ovaries volume in ml | Pelvic ultrasound (at 2nd-5th day of the menstrual cycle) | 1 day | Yes |
Secondary | Ovaries follicles diameter in mm | Pelvic ultrasound (at 2nd-5th day of the menstrual cycle) | 1 day | Yes |
Secondary | Chronic anovulation in number | Number of mentruals cycles in a year | 1 day | Yes |
Secondary | SHBG by nmol/l | Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea) | 1 day | Yes |
Secondary | Total serum testosterone by ng/dl | Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea) | 1 day | Yes |
Secondary | Ovaries follicles counting | Pelvic ultrasound (at 2nd-5th day of the menstrual cycle) | 1 day | Yes |
Secondary | Abdominal perimeter in cm | Measured at consultation | 1 day | Yes |
Secondary | Hip perimeter in cm | Measured at consultation | 1 day | Yes |
Secondary | Blood pressure in mmHg | Measured at consultation | 1 day | Yes |
Secondary | Testicular volume in ml | Measured at consultation | 1 day | Yes |
Secondary | LH in IU/L | Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea) | 1 day | Yes |
Secondary | FSH in IU/L | Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea) | 1 day | Yes |
Secondary | Oestradiol in ng/dl | Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea) | 1 day | Yes |
Secondary | DHEAS in micromol/l | Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea) | 1 day | Yes |
Secondary | 17 hydroxyprogesterone in ng/ml | Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea) | 1 day | Yes |
Secondary | Anti-Müllerian Hormone in ng/ml | Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea) | 1 day | Yes |
Secondary | Inhibine in pg/ml | Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea) | 1 day | Yes |
Secondary | Prolactine in microgr/L | Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea) | 1 day | Yes |
Secondary | Uterine diameter in mm | Pelvic ultrasound (at 2nd-5th day of the menstrual cycle) | 1 day | Yes |
Secondary | Uterine volume in ml | Pelvic ultrasound (at 2nd-5th day of the menstrual cycle) | 1 day | Yes |
Secondary | Endometrius thickness in mm | Pelvic ultrasound (at 2nd-5th day of the menstrual cycle) | 1 day | Yes |
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