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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

Thank you

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 Reproduction Charlottesville, Virginia  22902