RecruitingNCT06889454

Cardiovascular and Endothelial Markers During OGTT Before and at Six and Twelve Months Post-treatment in Women With PCOS

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


Sponsor

Attikon Hospital

Enrollment

120 participants

Start Date

Feb 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The aim of the present study is to investigate a) the presence of subclinical markers of vascular, myocardial and endothelial function in women with PCOS b) the acute alterations in these markers during the oral glucose tolerance test (OGTT) c) the impact of potential treatment interventions in these markers.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria7

  • Age \> 16 years old
  • 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)
  • Absence of treatment for PCOS the last six months
  • Patients who have the ability to understand and sign the consent form.

Exclusion Criteria7

  • 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
  • Treatment with contraceptive or metformin
  • Type 2 diabetes mellitus
  • Treatment for diabetes
  • Pregnancy
  • Lactation
  • Malignancy

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Interventions

DRUGGLP-1 receptor agonist

30 women will receive lifestyle modification and GLP-1 receptor agonists

DRUGOral contraceptive

30 women will receive lifestyle modification and oral contraceptive

DRUGMetformin

30 women will receive lifestyle modification and metformin

OTHERLifestyle modification

30 women will receive only lifestyle modification


Locations(1)

Attikon University General Hospital

Chaïdári, Greece

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NCT06889454


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