- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00581490
Biochemical and Radiological Indicators of Cardiovascular Morbidity in Children With Premature Pubarche (PP)
Study Overview
Status
Conditions
Detailed Description
Premature pubarche (PP), also called premature adrenarche (PA), is the early appearance of pubic hair before the age of 8 in girls and before 9 in boys. It had been shown that PP results from excess adrenal androgens. The terms PP and PA are used synonymously and differ from premature (precocious) puberty, the early activation of hypothalamic-pituitary gonadal axis. The incidence of PP is almost tenfold higher in girls than in boys. PP in the absence of congenital adrenal hyperplasia, virilizing ovarian or adrenal tumors has been regarded in the past as a benign phenomenon that may be associated with transient acceleration of growth and bone maturation and was not thought to have an adverse effect on the onset and progression of puberty and on final height in most patients. However, recent evidence suggests that hyperinsulinemia and obesity are common features in prepubertal and pubertal girls with a history of PP. Peri- and post-pubertal girls with PP exhibit an increase in incidence of hirsutism and polycystic ovary syndrome (PCOS). PCOS, a common hyperandrogenic disorder of women, is characterized by functional ovarian hyperandrogenism (FOH). FOH is defined as a 17-hydroxyprogesterone and/or androstenedione level >2 SD above that of the mean for control subjects after subcutaneous gonadotropin-releasing hormone agonist (GnRHa) stimulation during dexamethasone suppression of the adrenal glands. An increased risk of ovulatory dysfunction and FOH in adolescence detectable 3 years after menarche has also been reported in children diagnosed with PP. Serum triglyceride levels in premature adrenarche patients are higher when compared to controls throughout all stages of pubertal development. Boys with PP show reduced insulin sensitivity, independent of obesity, as observed in girls with PP. In Hispanic and Caribbean girls studies have shown prenatal influence on the development of PP. The lowest birth weights are found in this group of girls with PP who also have pronounced hyperinsulinism. Also, the presence of dyslipidemia in girls with PP depends on weight gain after birth. It has been shown that prepubertal girls are inherently more insulin resistant than boys which has been suggested to be related to the intrinsic difference in sex linked genes. Early metformin therapy prevents progression from PP to PCOS in a high risk group of former low birth weight girls, supporting the key role of insulin resistance in the ontogeny of PCOS.
Early intervention in PP can be initiated before marked obesity, diabetes, hypertension and increased cardiovascular morbidity related to insulin resistance become associated with endothelial dysfunction and abnormal vascular structure. Any intervention to decrease cardiovascular morbidity and mortality related to obesity and insulin resistance optimally begins in childhood. The short term goal of this proposal is to collect non-invasive evidence of cardiovascular disease morbidity risk factors at the time of PP diagnosis and to determine how they progress. Symptomatic endpoints used in most adult intervention trials, i.e. cardiac events and death, are not applicable in the setting of childhood disease.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Boys and girls with isolated premature pubarche
Exclusion Criteria:
- Congenital adrenal hyperplasia
- Precocious puberty
- Androgen producing tumors
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Idiopathic premature pubarche
Children with premature pubarche without precious puberty, adrenal hyperplasia or androgen secreting tumors
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in biometric and radiological features between subjects and matched controls
Time Frame: 6 years
|
6 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Revi P. Mathew, M.D., Vanderbilt University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 030292
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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