Clinical trial · Observational
Etiological Factors of Obesity-Associated Hyperandrogenemia in Peripubertal Girls
NCT00928759CI-TRIAL-00058548CRM002unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hyperandrogenemia | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- peripubertal obese girls
- description
- Peripubertal obese girls, aged 8 - 16 years, who are obese (BMI-for-age percentile greater or equal to 95)
Primary outcomes (2)
- measure
- Morning free testosterone
- timeFrame
- 0700 to 0900 hours
- measure
- Insulin-stimulated glucose disposal
- timeFrame
- 0900 to 1100 hours
Secondary outcomes (3)
- measure
- Estimated 24-hour mean insulin concentration
- timeFrame
- 24 hours
- measure
- Luteinizing hormone pulse frequency
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 8 Years
- Maximum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 17-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 * Abnormal sodium, potassium, bicarbonate concentrations, or elevated creatinine concentration * Weight less than 34 kg is an exclusion criterion (to ensure safe blood withdrawal) * Subjects using restricted medication (see restrictions below) are excluded unless the subject's primary care provider approves stopping the medication
References
Publications (1)
- DERIVEDBurt 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 29897474