Investigating cardiovascular markers in women with PCOS during glucose testing
The Effect of Different Treatment Options on Markers of Vascular, Myocardial and Endothelial Function in Women With Polycystic Ovary Syndrome and the Association With Metabolic and Hormonal Abnormalities of the Syndrome
This study is testing how glucose testing affects heart health markers in women with PCOS and whether different treatments can improve those markers over six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Attikon Hospital Academic / other |
| Locations | 1 site (Chaïdári) |
| Trial ID | NCT06889454 on ClinicalTrials.gov |
What this trial studies
This study aims to explore cardiovascular and endothelial function markers in women diagnosed with PCOS during an oral glucose tolerance test (OGTT). Participants will undergo measurements of glucose, insulin, and various cardiovascular parameters at specific intervals during the OGTT. Additionally, the study will assess the impact of treatment interventions such as GLP-1 receptor agonists, oral contraceptives, and lifestyle modifications on these markers over a six-month period. The primary endpoints focus on changes in global longitudinal strain, pulse wave velocity, and perfused boundary region during the OGTT and after treatment.
Who should consider this trial
Good fit: Ideal candidates are women over 16 years old with a diagnosis of PCOS who have not received treatment for the condition in the past six months.
Not a fit: Patients with conditions mimicking PCOS, such as thyroid disease or type 2 diabetes, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of cardiovascular risks in women with PCOS.
How similar studies have performed: While there have been studies on cardiovascular risks in PCOS, this specific approach focusing on acute changes during OGTT is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \> 16 years old 2. Diagonis of PCOS according to Rotterdam criteria: presence of two of the three of the following: * Clinical or biochemical hyperandrogenism * Anovulation or oligo-ovulation * Polycystic ovarian morphology (PCOM) 3. Absence of treatment for PCOS the last six months 4. Patients who have the ability to understand and sign the consent form. Exclusion Criteria: 1. Disorders with clinical presentation similar to PCOS: thyroid disease, hyperprolactinemia, and non-classic congenital adrenal hyperplasia (primarily 21-hydroxylase deficiency by serum 17-hydroxyprogesterone \[17-OHP\]), Cushing syndrome, acromegaly 2. Treatment with contraceptive or metformin 3. Type 2 diabetes mellitus 4. Treatment for diabetes 5. Pregnancy 6. Lactation 7. Malignancy
Where this trial is running
Chaïdári
- Attikon University General Hospital — Chaïdári, Greece (Recruiting)
Study contacts
- Study coordinator: VAIA lAMBADIARI, Professor
- Email: vlambad@otenet.gr
- Phone: 2105831148
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.