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

Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.