Sleep-wake Changes of Luteinizing Hormone Frequency in Pubertal Girls With and Without High Testosterone (CRM005)

This study is currently recruiting participants.
Verified January 2013 by University of Virginia
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Chris McCartney, University of Virginia
ClinicalTrials.gov Identifier:
NCT00930007
First received: June 24, 2009
Last updated: January 14, 2013
Last verified: January 2013

June 24, 2009
January 14, 2013
October 2008
October 2014   (final data collection date for primary outcome measure)
Luteinizing hormone pulse frequency (while awake and while asleep) [ Time Frame: Baseline (time zero) ] [ Designated as safety issue: No ]
LH pulse frequency (while awake and while asleep) [ Time Frame: Day 1 of study ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00930007 on ClinicalTrials.gov Archive Site
  • Progesterone concentration [ Time Frame: Baseline (time zero) ] [ Designated as safety issue: No ]
  • Estradiol concentration [ Time Frame: Baseline (time zero) ] [ Designated as safety issue: No ]
  • Testosterone concentrations [ Time Frame: Baseline (time zero) ] [ Designated as safety issue: No ]
  • Luteinizing hormone amplitude [ Time Frame: Baseline (time zero) ] [ Designated as safety issue: No ]
  • Sleep stage parameters [ Time Frame: Baseline (time zero) ] [ Designated as safety issue: No ]
  • Progesterone concentration [ Time Frame: Day 1 of study ] [ Designated as safety issue: No ]
  • Estradiol concentration [ Time Frame: Day 1 of study ] [ Designated as safety issue: No ]
  • Testosterone concentrations [ Time Frame: Day 1 of study ] [ Designated as safety issue: No ]
  • LH amplitude [ Time Frame: Day 1 of study ] [ Designated as safety issue: No ]
  • Sleep stage parameters [ Time Frame: Day 1 of study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Sleep-wake Changes of Luteinizing Hormone Frequency in Pubertal Girls With and Without High Testosterone
Comparison of Sleep-wake LH Frequency in Peripubertal Girls With and Without Hyperandrogenemia

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.

During early puberty, luteinizing hormone (LH) pulse frequency normally increases during sleep. In contrast, preliminary data suggest that obese girls (who have high testosterone levels in general) demonstrate low LH frequency during the day and night during early puberty; but at mid puberty rapidly transition to a high LH frequency during the day and night. We hypothesize that in early pubertal girls with high testosterone levels, overnight increases of LH frequency are less prominent than those observed in early pubertal girls with normal testosterone levels. We will assess this using a frequent sampling protocol for assessment of LH pulse frequency (with sampling occurring while awake and while asleep) in early pubertal girls with and without high testosterone levels. Sleep will be formally evaluated.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

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

Non-Probability Sample

Community sample and patients from local clinics

Hyperandrogenism
Not Provided
  • Hyperandrogenemic
    Girls with elevated free testosterone concentrations
  • Controls
    Girls with normal free testosterone concentrations
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
October 2014
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)
  • Hematocrit < 36% and hemoglobin < 12 g/dl (confirmed on repeat)
  • Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure; asthma requiring intermittent systemic corticosteroids; etc.)
  • Persistent liver test abnormalities (confirmed on repeat), with the exception that mild bilirubin elevations will be accepted in the setting of known Gilbert's syndrome
  • Persistently abnormal sodium, potassium, or elevated creatinine concentration (confirmed on repeat)
  • Bicarbonate concentrations < 20 or > 30 (confirmed on repeat)
  • No medications known to affect the reproductive system, glucose metabolism, lipid metabolism, or blood pressure can be taken in the 3 months prior to the first inpatient GCRC study (or in the 2 months prior to screening)

    • Such medications include oral contraceptive pills, progestins, metformin, glucocorticoids, psychotropics, and sympathomimetics/stimulants (e.g., methylphenidate)
    • Patients taking restricted medications will be excluded unless written permission (for the subjects to discontinue the medication) is received from the subject's physician
  • Weight < 22 kg is an absolute exclusion criterion (to ensure safe blood withdrawal)
Female
8 Years to 15 Years
Yes
Contact: Anne Gabel 434-243-6911 am7bd@virginia.edu
United States
 
NCT00930007
13950, R01HD058671
Yes
Chris McCartney, University of Virginia
University of Virginia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Christopher R McCartney, MD University of Virginia
University of Virginia
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP