ClinicalTrials.gov record NCT06889454

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old to 45 years old
SexFemale
LocationGreece
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective observational cohort follows women with PCOS to measure heart and blood-vessel function during an oral glucose tolerance test (OGTT) and again six months after treatment. Participants will have an OGTT with blood tests and repeated vascular and heart measurements (pulse wave velocity, coronary flow reserve, strain measures, flow-mediated dilation, microvascular glycocalyx, and carotid thickness). The study looks at how these markers change during the OGTT and how they change six months after the chosen treatment.

What it is studying. The study tests whether women with PCOS have subclinical vascular, myocardial and endothelial abnormalities, how these markers change acutely during an OGTT, and whether those markers change after treatment. It examines specific measures such as global longitudinal strain (heart strain), pulse wave velocity, perfused boundary region (microvascular glycocalyx), coronary flow reserve, flow-mediated dilation, carotid intima-media thickness, and metalloproteinase 9.

What the researchers hope to learn. Scientific goals: describe the presence of subclinical vascular, myocardial and endothelial markers in women with PCOS; document acute changes in these markers during an OGTT; and assess how these markers change six months after different treatment options (including GLP-1 receptor agonists, oral contraceptives, metformin, or lifestyle modification).

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • GLP-1 receptor agonist
  • Oral contraceptive
  • Metformin
Other
  • Lifestyle modification

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

You will have an oral glucose tolerance test (OGTT) with blood draws at 0, 60 and 120 minutes and simultaneous vascular/endothelial measurements (pulse wave velocity, augmentation index, and sublingual microvessel perfused boundary region). At 0 and 120 minutes you will also have heart ultrasound assessments (Doppler coronary flow reserve; speckle‑tracking measures of left ventricular strain and twisting), artery tests (flow‑mediated dilation and carotid intima‑media thickness), and blood tests for metabolic and hormone markers (including glucose, insulin, Testosterone, SHBG, DHEA‑s, PRL, 17‑OH‑PRG, Δ4/androstenedione, and metalloproteinase‑9). You will receive one of the treatment options listed in the record (GLP‑1 receptor agonist plus lifestyle, oral contraceptive plus lifestyle, metformin plus lifestyle, or lifestyle modification only) and repeat the same measurements six months after treatment. The registry title also mentions 12 months, but the record specifies repeat measurements at six months and does not clearly state the schedule for a 12‑month visit.

How the study is structured. A prospective observational cohort study. Women with PCOS undergo an OGTT with measurements at 0, 60 and 120 minutes (blood tests and vascular/heart measurements), additional heart and vessel tests at 0 and 120 minutes, and the same set of measurements repeated six months after they receive one of the treatments listed in the record. Participants are observed in groups receiving GLP-1 receptor agonists, oral contraceptives, metformin, or lifestyle modification (30 women per group as listed).

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under PCOS; Hyperinsulinism; Hyperandrogenism; Metabolic Syndrome. Does it apply to my diagnosis?
  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Greece. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start
Feb 1, 2024
Primary completion
Feb 1, 2025
Study completion
Feb 1, 2026 (estimated)
Target enrollment
120 participants (estimated)
Last updated on registry
Nov 19, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Attikon Hospital
Principal investigator
VAIA LAMBADIARI, Professor of Internal Medicine-Endocrinology
Attikon Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
echocardiography
An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
Endpoints
Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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