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Идёт набор NCT06889454

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

— Наблюдательное PCOS Hyperinsulinism Hyperandrogenism Metabolic Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: GLP-1 receptor agonist, Oral contraceptive, Metformin, Lifestyle modification.
Кому может быть актуально
Состояния в реестре: PCOS, Hyperinsulinism, Hyperandrogenism, Metabolic Syndrome. Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Греция
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Препарат GLP-1 receptor agonist
    30 women will receive lifestyle modification and GLP-1 receptor agonists
  • Препарат Oral contraceptive
    30 women will receive lifestyle modification and oral contraceptive
  • Препарат Metformin
    30 women will receive lifestyle modification and metformin
  • Другое Lifestyle modification
    30 women will receive only lifestyle modification

Первичные конечные точки

  • Τhe change in Global Longitudinal Strain during Oral glucose Tolerance Test [Срок оценки: 120 minute of Oral glucose Tolerance Test]
  • The change in Pulse Wave Velocity during Oral glucose Tolerance Test [Срок оценки: 120minute of Oral glucose Tolerance Test]
  • The change in Perfused Boundary Region during Oral glucose Tolerance Test [Срок оценки: 120minute of Oral glucose Tolerance Test]
  • The change in Global Longitudinal Strain [Срок оценки: six months]
  • The change in Pulse Wave Velocity [Срок оценки: six months]
  • The change in Perfused Boundary Region [Срок оценки: six months]
  • The change in Metalloproteinase 9 [Срок оценки: six months]
Вторичные конечные точки (4)
  • Τhe change in Coronary flow reserve during Oral glucose Tolerance Test [Срок оценки: 120 min of Oral glucose Tolerance Test]
  • Τhe change in Flow mediated Dilation during Oral glucose Tolerance Test [Срок оценки: 120min of Oral glucose Tolerance Test]
  • The change in Coronary flow reserve [Срок оценки: six months]
  • The change in Flow mediated Dilation [Срок оценки: six months]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Греция · 1 центр
  • Attikon University General Hospital — Chaïdári

Идентификаторы

NCT: NCT06889454 · PCOS_OGTT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗