Urinary DENND1A.V2 as a Predictor of Pubertal Hyperandrogenemia (DENND1A)
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ClinicalTrials.gov Identifier: NCT02611128 |
Recruitment Status :
Suspended
(temporarily closed to enrollment due to COVID)
First Posted : November 20, 2015
Last Update Posted : October 14, 2020
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Condition or disease | Intervention/treatment |
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Polycystic Ovary Syndrome Hyperandrogenism Puberty | Other: Phenotype/genotype assessment |

Study Type : | Observational |
Estimated Enrollment : | 65 participants |
Observational Model: | Other |
Time Perspective: | Cross-Sectional |
Official Title: | Urinary DENND1A.V2 as a Predictor of Pubertal Hyperandrogenemia |
Actual Study Start Date : | May 29, 2015 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | December 2021 |

Group/Cohort | Intervention/treatment |
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Peripubertal girls
Peripubertal girls with varying androgen concentrations will have careful phenotype/genotype assessment, primarily to assess the relationship between urinary exosomal DENND1A.V2 and serum free testosterone concentrations.
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Other: Phenotype/genotype assessment
The investigators will perform careful phenotyping in addition to hormonal assessments and assessments of DENND1A |
- Urinary exosomal DENND1A.V2 [ Time Frame: Day 1 of study (the study involves one outpatient visit) ]Urinary exosomal DENND1A.V2
- Serum free testosterone [ Time Frame: Day 1 of study (the study involves one outpatient visit) ]Calculated free testosterone
- Bone age [ Time Frame: Day 1 of study (the study involves one outpatient visit) ]A measure of maturational stage
- BMI z-score [ Time Frame: Day 1 of study (the study involves one outpatient visit) ]Body mass index normalized for age and gender
- Morning luteinizing hormone [ Time Frame: Day 1 of study (the study involves one outpatient visit) ]Serum luteinizing hormone (LH) measured at same time as free testosterone and fasting insulin
- Fasting insulin [ Time Frame: Day 1 of study (the study involves one outpatient visit) ]Serum insulin measured at same time as free testosterone and morning LH
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 8 Years to 17 Years (Child) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02611128
United States, Virginia | |
Center for Research in Reproduction | |
Charlottesville, Virginia, United States, 22908 |
Principal Investigator: | Christopher McCartney, MD | University of Virginia |
Responsible Party: | Chris McCartney, Associate Professor of Medicine, University of Virginia |
ClinicalTrials.gov Identifier: | NCT02611128 |
Other Study ID Numbers: |
17633 P50HD028934 ( U.S. NIH Grant/Contract ) |
First Posted: | November 20, 2015 Key Record Dates |
Last Update Posted: | October 14, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | We do not have current plans to share IPD |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Polycystic Ovary Syndrome Hyperandrogenism Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases |
Gonadal Disorders Endocrine System Diseases 46, XX Disorders of Sex Development Disorders of Sex Development Urogenital Abnormalities Adrenogenital Syndrome Congenital Abnormalities |