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Effect of Metformin on Adrenal or Ovarian Androgen Production in Overweight Pubertal Girls With Androgen Excess (CBS005)


N/A
7 Years
18 Years
Not Enrolling
Female
Obesity, Hyperandrogenemia, Polycystic Ovary Syndrome

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Trial Information

Effect of Metformin on Adrenal or Ovarian Androgen Production in Overweight Pubertal Girls With Androgen Excess (CBS005)


Inclusion Criteria:



- overweight(>85th BMI%) females

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

- Hyperandrogenemic (free testosterone greater than 2.5 standard deviations above the
mean for normal control subjects of the same Tanner Stage)

- 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:

- Age < 7 or > 18 y

- Inability to comprehend what will be done during the study or why it will be done

- BMI-for-age < 5th percentile

- Positive pregnancy test or lactation.

- Abnormal laboratory studies will be confirmed by repeat testing to exclude laboratory
error.

- Morning cortisol < 3 µg/dL or history of Cushing syndrome or adrenal insufficiency

- History of congenital adrenal hyperplasia or 17-hydroxyprogesterone > 300 ng/dL,
which suggests the possibility of congenital adrenal hyperplasia (if postmenarcheal,
the 17-hydroxyprogesterone will be collected during the follicular phase, or ≥ 40
days since last menses if oligomenorrheic). NOTE: If a 17-hydroxyprogesterone >300
mg/dL is confirmed on repeat testing, an ACTH-stimulated 17-hydroxyprogesterone <1000
ng/dL will be required for study participation.

- Total testosterone > 150 ng/dL, which suggests the possibility of a virilizing
neoplasm

- DHEAS greater than the upper limit of age-appropriate normal range (mild elevations
may be seen in PCOS and adolescent HA, and elevations < 1.5 times the age-appropriate
upper limit of normal will be accepted in these groups)

- Virilization

- Previous diagnosis of diabetes, fasting glucose ≥126 mg/dL, or a hemoglobin A1c ≥6.5%

- Abnormal thyroid stimulating hormone (TSH) for age. Subjects with stable and
adequately treated hypothyroidism, reflected by normal TSH values, will not be
excluded.

- Abnormal prolactin. Mild elevations may be seen in overweight girls, and elevations
<1.5 times the upper limit of normal will be accepted in this group.

- Persistent hematocrit <36% and hemoglobin <12 g/dL. Subjects with a mildly low
hematocrit (33-36%) will be asked to take iron in the form of ferrous gluconate for
up to 60 days. Subjects weighing ≤ 36 kg will take one 300-325 mg tablet oral ferrous
gluconate daily (containing 36 mg elemental iron);subjects weighing >36 kg will take
two 300-325 mg tablets oral ferrous gluconate daily (containing 36 mg elemental iron
each). They will return to the CRC after 30-60 days of iron therapy to have their
hemoglobin or hematocrit rechecked and will proceed with the remainder of the study
if it is ≥12 g/dL or ≥36%, respectively.

- Persistent liver test abnormalities, with the exception that mild bilirubin
elevations will be accepted in the setting of known Gilbert's syndrome. Mild
elevations may be seen in overweight girls, so elevations <1.5 times the upper limit
of normal will be accepted in this group.

- Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected
congestive heart failure; asthma requiring intermittent systemic corticosteroids;
etc.)

- Abnormal sodium, potassium, or bicarbonate concentrations, or elevated creatinine
concentration (confirmed on repeat)

- No medications known to affect the reproductive system or glucose metabolism can be
taken in the 3 months prior to the study. Such medications include oral contraceptive
pills, progestins, metformin, glucocorticoids, and psychotropics.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Changes in free testosterone or 17 OH progesterone levels after ACTH and r-hCG administration respectively, before and after metformin administration for 12 weeks

Outcome Time Frame:

12 weeks after metformin administration

Safety Issue:

No

Principal Investigator

Christine Burt Solorzano, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia

Authority:

United States: Institutional Review Board

Study ID:

CBS005

NCT ID:

NCT01422746

Start Date:

Completion Date:

Related Keywords:

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

Name

Location

University of Virginia Center for Research in ReproductionCharlottesville, Virginia  22902