Actively Recruiting

Age: 18Years - 45Years
FEMALE
ID06889454

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

Led by Attikon Hospital · Updated on 2025-11-19

120

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying women with Polycystic Ovary Syndrome (PCOS) to investigate markers related to blood vessel, heart muscle, and inner vessel lining function. The study looks at these markers both before and during a glucose tolerance test, as well as changes after treatment. It explores how metabolic and hormonal abnormalities in PCOS affect these markers and evaluates the impact of different treatments over time. Participants will be divided into four groups: one group will receive lifestyle changes combined with a GLP-1 receptor agonist drug, another will receive lifestyle changes with an oral contraceptive, a third group will receive lifestyle changes with metformin, and the last group will receive lifestyle changes alone. After six months of treatment, the same tests will be repeated to observe changes. Tests include glucose and insulin levels, arterial stiffness, heart function using echocardiography, blood vessel dilation, and hormone levels. During the study, women will undergo detailed measurements at baseline, during the oral glucose tolerance test at multiple time points, and after six months of treatment. These assessments include blood tests, heart ultrasound scans, and blood vessel function tests. Researchers will track changes in heart strain, arterial stiffness, and blood vessel lining thickness as primary outcomes. Secondary outcomes include changes in coronary flow and blood vessel dilation. The study will last over a year with follow-up assessments at six and twelve months.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 16 years old
  • Diagnosis of PCOS based on Rotterdam criteria with two of the following: clinical or biochemical hyperandrogenism, anovulation or oligo-ovulation, polycystic ovarian morphology
  • No PCOS treatment in the last six months
  • Ability to understand and sign the consent form
Not Eligible

You will not qualify if you...

  • Disorders similar to PCOS such as thyroid disease, hyperprolactinemia, non-classic congenital adrenal hyperplasia, Cushing syndrome, or acromegaly
  • Current treatment with contraceptives or metformin
  • Type 2 diabetes mellitus or treatment for diabetes
  • Pregnancy or lactation
  • Presence of malignancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Baseline Assessment

Duration - 1 day

Participants undergo oral glucose tolerance testing (OGTT) with various cardiovascular and hormonal measurements taken at 0, 60, and 120 minutes.

1 visit (in-person)

Treatment

Duration - 6 months

Participants receive one of the following for six months: lifestyle modification alone or combined with GLP-1 receptor agonists, oral contraceptives, or metformin.

Monthly or routine visits as per treatment plan

Follow-up Assessment

Duration - 1 day

After six months of treatment, participants undergo the same OGTT and cardiovascular and hormonal measurements as at baseline to evaluate changes.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Attikon University General Hospital

Chaïdári, Greece, 124 62

Actively Recruiting

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Research Team

V

VAIA lAMBADIARI, Professor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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