Clinical trial · Observational
Blood Vessel Function in Adolescents and Women With Polycystic Ovary Syndrome
Endothelial Dysfunction in Adolescents and Women With Polycystic Ovary Syndrome (PCOS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty in enrolling suitable subjects
Summary
Brief summary (as posted)
The purpose of this study is to determine if changes in blood vessel health lead to the menstrual irregularities that women with PCOS experience. This research study will help determine if women with PCOS have early changes in their blood vessels called "endothelial dysfunction," and if the number of progenitor cells (cells that in a healthy person repair blood vessel damage) are related to these blood vessel changes. To do so, we will compare ultrasound (soundwave) pictures of a large blood vessel in the arm and the results of blood tests between women with PCOS and other healthy women with normal menstrual periods.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome (PCOS) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- PCOS adolescents
- description
- Post-menarchal females ages 14-17 with and without PCOS (15 each group for a total of 30 subjects).
- label
- PCOS women
- description
- Women ages 18-40 with and without PCOS (15 each group for a total of 30 subjects).
Primary outcomes (1)
- measure
- Peripheral vascular imaging via ultrasonography during brachial artery flow-mediated vasodilation (FMD)
- timeFrame
- ~ 30 minutes
- description
- A blood pressure cuff is placed on right forearm. A 7-12MHz linear array ultrasound transducer is placed on upper arm. 2-D and Doppler images are acquired. Forearm cuff is inflated to \~ 50 mmHg above resting systolic blood pressure (max 300 mmHg) for 4.5 minutes, then deflated. Blood flow velocity via Doppler is recorded for 15 seconds; 2D-images of the brachial artery are collected for 3 minutes. Brachial artery diameter is measured at end diastole (R-wave on ECG).FMD is determined: %FMD=(LDp-LDb)/LDbx100, where LDp=luminal diameter after inflation and LDb=luminal diameter at baseline
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 14 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * PCOS as defined by NIH/NICHD criteria: 1) oligo- or amenorrhea (≤8 menstrual periods annually, persisting 2 years post menarche); 2) biochemical hyperandrogenism(HA), i.e.,elevated total or free testosterone concentration and/or clinical evidence of HA (defined as the presence of hirsutism); and 3) exclusion of secondary causes of ovulatory dysfunction and HA (including hyperprolactinemia, thyroid dysfunction, non-classical congenital adrenal hyperplasia (NCAH) due to 21-hydroxylase deficiency, Cushing syndrome, androgen secreting neoplasms, and androgenic/anabolic drug use). * Inclusion criteria for adolescent and adult control subjects will include 1) normal menstrual periods (defined as regular cycles between 22-36 days in length); 2) normal serum androgens (total/free testosterone and dehydroepiandrosterone-sulfate \[DHEA-S\]); and 3) absence of clinical evidence of hyperandrogenism. Additionally, adolescent controls must be 2 years post menarche. Exclusion Criteria: * Diabetes mellitus * Underlying endocrine, neurologic, and/or genetic syndromes leading to obesity * Congenital heart disease or abnormal resting ECG * Renal or hepatic disease * History of rheumatologic disorders or malignancy * Use of medications or dietary supplements known to affect insulin sensitivity (i.e. metformin, corticosteroids, and oral contraceptive pills), blood pressure, or cholesterol within 3 months of study participation * Investigation drug use within 3 months of study participation * Pregnancy * Current tobacco use
References
Publications (0)
Data not yet available