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

Official 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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

• Τhe change in Global Longitudinal Strain during Oral glucose Tolerance Test [Time frame: 120 minute of Oral glucose Tolerance Test]
• The change in Pulse Wave Velocity during Oral glucose Tolerance Test [Time frame: 120minute of Oral glucose Tolerance Test]
• The change in Perfused Boundary Region during Oral glucose Tolerance Test [Time frame: 120minute of Oral glucose Tolerance Test]
• The change in Global Longitudinal Strain [Time frame: six months]
• The change in Pulse Wave Velocity [Time frame: six months]
• The change in Perfused Boundary Region [Time frame: six months]
• The change in Metalloproteinase 9 [Time frame: six months]

Secondary outcome measures (4)

• Τhe change in Coronary flow reserve during Oral glucose Tolerance Test [Time frame: 120 min of Oral glucose Tolerance Test]
• Τhe change in Flow mediated Dilation during Oral glucose Tolerance Test [Time frame: 120min of Oral glucose Tolerance Test]
• The change in Coronary flow reserve [Time frame: six months]
• The change in Flow mediated Dilation [Time frame: six months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Greece · 1 center

• Attikon University General Hospital — Chaïdári

Identifiers

NCT: NCT06889454 · PCOS_OGTT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗