NCT00928759

Brief Summary

The purpose of this study is to learn if obese pre- and early pubertal girls with hyperandrogenemia (HA) are more insulin resistant (i.e., have lower insulin-stimulated glucose disposal) compared to obese peripubertal girls without HA; and that overnight mean luteinizing hormone (LH) concentration is also an independent predictor of free testosterone concentrations, especially in mid- to late pubertal girls.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2008

Completed
8 months until next milestone

First Posted

Study publicly available on registry

June 26, 2009

Completed
13.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

15.2 years

First QC Date

October 28, 2008

Last Update Submit

May 16, 2022

Conditions

ObesityHyperandrogenemiaPolycystic Ovary Syndrome

Keywords

ObesityPolycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (2)

  • Morning free testosterone

    0700 to 0900 hours

  • Insulin-stimulated glucose disposal

    0900 to 1100 hours

Secondary Outcomes (3)

  • Estimated 24-hour mean insulin concentration

    24 hours

  • Luteinizing hormone pulse frequency

    1800 to 0900 hours

  • Mean luteinizing hormone concentration

    1800 to 0900 hours

Study Arms (1)

peripubertal obese girls

Peripubertal obese girls, aged 8 - 16 years, who are obese (BMI-for-age percentile greater or equal to 95)

Eligibility Criteria

Age8 Years - 16 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Generally healthy peripubertal girls ages 8 - 16 years with a BMI of \> or = to 95th percentile will be recruited from the general population of the surrounding area.

You may qualify if:

  • Peripubertal (Tanner stage 1 to 5) girl, age 8-16 years
  • Obesity (BMI-for-age ≥ 95th percentile)
  • Generally healthy (save for exogenous obesity)
  • Ability and willingness of subject/parents to provide informed assent/consent

You may not qualify if:

  • Age \< 8 or \> 16 y
  • Greater than 4 y post-menarche
  • 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, which suggests the possibility of a virilizing neoplasm
  • DHEAS greater than twice upper limit of age-appropriate normal range
  • OHP greater than 250 ng/dl, which suggests the possibility of congenital adrenal hyperplasia (if postmenarcheal, the 17-OHP will be collected during the follicular phase, or \> 60 if oligomenorrheic) NOTE: If a 17-OHP \> 250 ng/dl is confirmed on repeat testing, an ACTH stimulation test will be offered, with a post-ACTH 17-OHP \< 1000 ng/dl being required for study participation
  • History of premature adrenarche (i.e., appearance of pubic and/or axillary hair before age 8)
  • Fasting glucose \> 125 mg/dl or hemoglobin A1c \> 7.0%
  • Abnormal TSH or prolactin
  • Evidence of Cushing's syndrome by history or physical exam (e.g., history of impaired growth, striae)
  • Hematocrit \< 36% or hemoglobin \< 12 g/dl
  • Significant and current cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure; asthma requiring systemic intermittent corticosteroids; etc.)
  • Abnormal liver enzymes, age-specific alkaline phosphatase, or a bilirubin \> 1.5 times upper limit of normal
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

Related Publications (1)

  • Burt Solorzano CM, Knudsen KL, Anderson AD, Hutchens EG, Collins JS, Patrie JT, Marshall JC, McCartney CR. Insulin Resistance, Hyperinsulinemia, and LH: Relative Roles in Peripubertal Obesity-Associated Hyperandrogenemia. J Clin Endocrinol Metab. 2018 Jul 1;103(7):2571-2582. doi: 10.1210/jc.2018-00131.

    PMID: 29897474DERIVED

MeSH Terms

Conditions

ObesityPolycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Christopher McCartney, MD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Gilrain

CONTACT

434-243-6911pcos@virginia.edu

Christopher McCartney, MD

CONTACT

434-243-6911cm2hq@virginia.edu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

October 28, 2008

First Posted

June 26, 2009

Study Start

March 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)