Clinical trial NCT06889454: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: PCOS
Hyperinsulinism
Hyperandrogenism
Metabolic Syndrome
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with PCOS

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Age \> 16 years old
2. 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)
3. Absence of treatment for PCOS the last six months
4. Patients who have the ability to understand and sign the consent form.

Exclusion Criteria:

1. 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
2. Treatment with contraceptive or metformin
3. Type 2 diabetes mellitus
4. Treatment for diabetes
5. Pregnancy
6. Lactation
7. Malignancy

Primary outcomes:
measure: Τhe change in GLS during OGTT
timeFrame: 120 min of OGTT
measure: The change in PWV during OGTT
timeFrame: 120min of OGTT
measure: The change in PBR during OGTT
timeFrame: 120min of OGTT
measure: The change in GLS
timeFrame: six months
measure: The change in PWV
timeFrame: six months
measure: The change in PBR
timeFrame: six months
measure: The change in Metalloproteinase 9
timeFrame: six months
Secondary outcomes:
measure: Τhe change in CFR during OGTT
timeFrame: 120 min of OGTT
measure: Τhe change in FMD during OGTT
timeFrame: 120min of OGTT
measure: The change in CFR
timeFrame: six months
measure: The change in FMD
timeFrame: six months
Other outcomes:
Locations:
city: Chaidari
country: Greece
facility: Attikon University General Hospital
Study officials:
References: