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Trial record 1 of 1 for:    NCT00581490
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Biochemical and Radiological Indicators of Cardiovascular Morbidity in Children With Premature Pubarche (PP)

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ClinicalTrials.gov Identifier: NCT00581490
Recruitment Status : Completed
First Posted : December 27, 2007
Last Update Posted : April 4, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Vanderbilt University Medical Center

Tracking Information
First Submitted Date December 20, 2007
First Posted Date December 27, 2007
Last Update Posted Date April 4, 2017
Study Start Date August 2003
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 26, 2007)
Changes in biometric and radiological features between subjects and matched controls [ Time Frame: 6 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biochemical and Radiological Indicators of Cardiovascular Morbidity in Children With Premature Pubarche
Official Title Biochemical and Radiological Indicators of Cardiovascular Morbidity in Children With Premature Pubarche
Brief Summary Children with premature pubarche will have radiological and radial artery tonometry evidence of cardiovascular morbidity at diagnosis when compared to matched controls.
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 Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
DNA sample from consented subjects and controls
Sampling Method Probability Sample
Study Population Boys below the age of 9; girls below the age of 8 if Caucasian and below age 6 if African American
Condition Evidence of Cardiovascular Morbidity
Intervention Not Provided
Study Groups/Cohorts Idiopathic premature pubarche
Children with premature pubarche without precious puberty, adrenal hyperplasia or androgen secreting tumors
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 30, 2017)
52
Original Estimated Enrollment
 (submitted: December 26, 2007)
24
Actual Study Completion Date June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Boys and girls with isolated premature pubarche

Exclusion Criteria:

  • Congenital adrenal hyperplasia
  • Precocious puberty
  • Androgen producing tumors
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years to 9 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00581490
Other Study ID Numbers 030292
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Vanderbilt University Medical Center
Study Sponsor Vanderbilt University Medical Center
Collaborators Pfizer
Investigators
Principal Investigator: Revi P. Mathew, M.D. Vanderbilt University
PRS Account Vanderbilt University Medical Center
Verification Date March 2017