Last updated on April 2019

Urinary DENND1A.V2 as a Predictor of Pubertal Hyperandrogenemia


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Polycystic Ovary Syndrome | Puberty | Hyperandrogenism
  • Age: Between 8 - 17 Years
  • Gender: Female

List of Inclusion Criteria

Peripubertal girls, Tanner breast stages 1-5

List of Exclusion Criteria

  • Age < 8 or > 17 y
  • Men and boys are excluded
  • Inability to obtain proper consent/assent
  • Atypical obesity
  • Underweight: Underweight is defined as a BMI-for-age percentile < 5
  • Positive pregnancy test or lactation
  • Assessment during the luteal phase as suggested by a serum progesterone 1.5 ng/ml
  • Virilization or a total testosterone > 150 ng/dl
  • Excessively elevated DHEA-S: This will be defined as a DHEA-S > 1.5 times the age-appropriate upper limit of normal
  • Congenital adrenal hyperplasia (CAH)
  • Cortisol deficiency/excess
  • Inadequately-treated or unstable thyroid dysfunction
  • Significant hyperprolactinemia: Since mild elevations may be seen in girls with hyperandrogenemia or PCOS, elevations up to 30 (i.e., 1.5 times the upper limit of normal) will be accepted in such girls
  • Significant chronic medical history: This includes a significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure; asthma requiring intermittent systemic corticosteroids; etc.); history of renal insufficiency or durable electrolyte abnormalities; or a history of substantial liver disease. A history of liver test abnormalities will be allowed in two circumstances: (1) mild bilirubin elevations will be accepted in the setting of known Gilbert's syndrome; (2) mild transaminase (ALT, AST) elevations may be seen in obese girls, so stable elevations < 1.5 times the upper limit of normal will be accepted in this group.
  • Uncontrolled type 2 diabetes mellitus: This will be reflected by a hemoglobin A1c > 7.0%. Subjects with impaired glucose tolerance or a diagnosis of type 2 diabetes that is well-controlled with lifestyle management alone will be allowed to participate.
  • Type 1 diabetes mellitus: Since subjects with type 1 diabetes invariably require exogenous insulin, they will not be allowed to participate.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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