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Evaluation of Adrenal Androgens in Normal and Obese Girls After Suppression and Stimulation (JCM022)


N/A
7 Years
18 Years
Open (Enrolling)
Female
Hyperandrogenemia, Polycystic Ovary Syndrome, Obesity

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Trial Information

Evaluation of Adrenal Androgens in Normal and Obese Girls After Suppression and Stimulation (JCM022)


Inclusion Criteria:



- Normal and obese (>95th BMI%) females

- Weight of 24 kg or more

- Early to late puberty (expected age range 7-18)

- Screening labs within age-appropriate normal range, with the exception of a mildly
low hematocrit (see below) and the hormonal abnormalities inherent in obesity which
could include mildly elevated LH, lipids, testosterone, prolactin, DHEAS, E2,
glucose, and insulin and decreased FSH and/or SHBG

Exclusion Criteria:

- Screening labs outside of age-appropriate normal range

- Hemoglobin <12 mg/dL and hematocrit<36% (Subjects will be offered the opportunity to
take iron supplementation for 60 days if their hematocrit is slightly low (33-36%)
(suggestive of iron deficiency anemia) and will then return for retesting of their
hemoglobin/hematocrit. If still <36%, they will be excluded.)

- Morning Cortisol <5 g/dL

- 17-hydroxyprogesterone >295 ng/dL

- Weight<24 kg

- History of Cushing's syndrome or adrenal insufficiency

- Pregnant (self reported)

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Change in progesterone concentrations from the 2100-2300 time block to teh 0500-0700 time block in normal weight girls compared to overweight girls.

Outcome Description:

A primary endpoint for analysis in this study is the change in progesterone concentrations from the 2100-2300 time block to the 0500-0700 time block in normal weight girls compared to overweight girls.

Outcome Time Frame:

Time frame for the study will be 14 hours (Sampling begins at 1900 hrs and proceeds through 0800 hours the following morning).

Safety Issue:

No

Principal Investigator

John C Marshall, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia

Authority:

United States: Institutional Review Board

Study ID:

12702

NCT ID:

NCT01421797

Start Date:

October 2006

Completion Date:

March 2015

Related Keywords:

  • Hyperandrogenemia
  • Polycystic Ovary Syndrome
  • Obesity
  • Obesity
  • Polycystic Ovary Syndrome

Name

Location

University of Virginia Center for Research in ReproductionCharlottesville, Virginia  22902