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NCT Number: NCT06889454

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

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.

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Key information

About this study

All the woman who will recruited in the study will undergo OGTT. At 0, 60, and 120 min of glucose load the investigators will measure: a) glucose and insulin, b) pulse wave velocity (PWV) c) augmentation index (Aix) and d) perfused boundary region of sublingual microvessels (high PBR values represent reduced glycocalyx thickness). At 0 and 120 min of glucose load, the investigators will assess: a) coronary flow reserve (CFR) using Doppler echocardiography, b) LV longitudinal strain (LS) of subendocardial, mid-myocardial and subepicardial layers and global LS (GLS) c) peak twisting (pTw), untwisting velocity (pUtwVel) by speckle tracking echocardiography d) flow mediated dilation (FMD) of the brachial artery, e) Carotid intima-media thickness. Matsuda index, insulin sensitivity index (ISI) and HOMA index will be also measured. The levels of Testosterone (Τesto), Sex hormone binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEA-s), Prolactin (PRL), 17-hydroxyprogesterone (17-OH-PRG) ,Androstenedione (Δ4) and Metalloproteinase 9 will be also assessed. After six months of treatment intervention, the patient will undergo the previously described measurements. Primary Endpoints include the change in GLS, PWV, and PBR during OGTT and six months after treatment intervention. Secondary Endpoints include the change in CFR and FMD during OGTT and six months after treatment intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

GLP-1 receptor agonist

Drug

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

Oral contraceptive

Drug

30 women will receive lifestyle modification and oral contraceptive

metformin

Drug

30 women will receive lifestyle modification and metformin

lifestyle modification

Other

30 women will receive only lifestyle modification

Primary outcomes

  1. Τhe change in Global Longitudinal Strain during Oral glucose Tolerance Test

    Time frame: 120 minute of Oral glucose Tolerance Test

    Τhe change in Global Longitudinal Strain at 0 and 120 minute after glucose load

  2. The change in Pulse Wave Velocity during Oral glucose Tolerance Test

    Time frame: 120minute of Oral glucose Tolerance Test

    The change in Pulse Wave Velocity at 0 and 120 minute after glucose load

  3. The change in Perfused Boundary Region during Oral glucose Tolerance Test

    Time frame: 120minute of Oral glucose Tolerance Test

    The change in Perfused Boundary Region at 0 and 120 minute after glucose load

  4. The change in Global Longitudinal Strain

    Time frame: six months

    The change in Global Longitudinal Strain 6 months after treatment intervention

  5. The change in Pulse Wave Velocity

    Time frame: six months

    The change in Pulse Wave Velocity 6 months after treatment intervention

  6. The change in Perfused Boundary Region

    Time frame: six months

    The change in Perfused Boundary Region 6 months after treatment intervention

  7. The change in Metalloproteinase 9

    Time frame: six months

    The change in Metalloproteinase 9 six months after tretament intervention

Secondary outcomes

  1. Τhe change in Coronary flow reserve during Oral glucose Tolerance Test

    Time frame: 120 min of Oral glucose Tolerance Test

    Τhe change in Coronary flow reserve at 0 and 120 min after glucose load

  2. Τhe change in Flow mediated Dilation during Oral glucose Tolerance Test

    Time frame: 120min of Oral glucose Tolerance Test

    Τhe change in Flow mediated Dilation at 0 and 120 min after glucose load

  3. The change in Coronary flow reserve

    Time frame: six months

    The change in Coronary flow reserve 6 months after treatment intervention

  4. The change in Flow mediated Dilation

    Time frame: six months

    The change in Flow mediated Dilation 6 months after treatment intervention

Study contacts

Contact information is provided by the study sponsor or research team.

VAIA lAMBADIARI, Professor

CONTACT

[email protected]

2105831148

Sponsors and collaborators

Lead sponsor

Attikon Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 21, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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