Sleep-wake Changes of Luteinizing Hormone Frequency in Pubertal Girls With and Without High Testosterone

NCT00930007 | Unknown DMC

• 1 other identifier: 13950
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether sleep-wake changes of luteinizing hormone pulse frequency are different in early pubertal girls with high testosterone levels compared to early pubertal girls with normal testosterone levels.

Conditions

Hyperandrogenism

Keywords

Luteinizing hormone; Puberty

Outcome Measures

Primary Outcomes (1)

• Luteinizing hormone pulse frequency (while awake and while asleep)

  Baseline (time zero)

Secondary Outcomes (5)

• Progesterone concentration

  Baseline (time zero)

• Estradiol concentration

  Baseline (time zero)

• Testosterone concentrations

  Baseline (time zero)

• Luteinizing hormone amplitude

  Baseline (time zero)

• Sleep stage parameters

  Baseline (time zero)

Study Arms (2)

Hyperandrogenemic

Girls with elevated free testosterone concentrations

Other: Blood sampling

Controls

Girls with normal free testosterone concentrations

Other: Blood sampling

Interventions

Blood sampling OTHER

Blood sampling for later hormone measurements

Controls; Hyperandrogenemic

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Community sample and patients from local clinics

You may qualify if:

• Early to midpubertal girls (late Tanner 1 \[i.e., estradiol \> 20 pg/ml\] to Tanner 3)
• Premenarcheal
• Approximate ages, 8-15 years

You may not qualify if:

• BMI-for-age \< 5th percentile
• Inability to comprehend what will be done during the study or why it will be done
• Being a study of GnRH pulse regulation in adolescent girls with and without HA, boys are excluded
• Obesity associated with a diagnosed (genetic) syndrome (e.g., Prader-Willi syndrome, leptin deficiency), obesity related to medications (e.g., glucocorticoids), etc.
• Pregnancy or lactation
• Virilization
• Total testosterone \> 150 ng/dl (confirmed on repeat)
• DHEAS \> upper limit of age-appropriate normal range (confirmed on repeat) (mild elevations may be seen in adolescent HA, and elevations \< 1.5 times the age-appropriate upper limit of normal will be accepted in such girls)
• Follicular phase 17-hydroxyprogesterone \> 250 ng/dl (for girls \< 12 years old) or \> 300 ng/dl (for girls 12 and older) (confirmed on repeat), which suggests the possibility of congenital adrenal hyperplasia. NOTE: If an elevated follicular 17-hydroxyprogesterone is confirmed on repeat testing, an ACTH stimulated 17-hydroxyprogesterone \< 1000 ng/dl will be required for study participation
• History of premature adrenarche (i.e., appearance of pubic and/or axillary hair before age 8)
• A previous diagnosis of diabetes
• Fasting glucose ≥ 126 mg/dl, or a hemoglobin A1c \> 6.5% (confirmed on repeat)
• Abnormal TSH (confirmed on repeat) (subjects with adequately treated hypothyroidism, reflected by normal TSH values, will not be excluded)
• Abnormal prolactin (confirmed on repeat) (mild elevations may be seen in HA girls, and elevations \< 1.5 times the upper limit of normal will be accepted in this group)
• Evidence of Cushing's syndrome by history or physical exam (e.g., history of impaired growth in children, striae)

Sponsors & Collaborators

• University of Virginia: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum obtained during frequent sampling will be stored (in case repeat measurements are required), but will be discarded at the end of the study

MeSH Terms

Conditions

Hyperandrogenism

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Christopher R McCartney, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: June 24, 2009
• First Posted: June 30, 2009
• Study Start: October 1, 2008
• Primary Completion: May 1, 2023
• Study Completion: August 1, 2023
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

US (1)