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

Attikon University Hospital

Status: Enrolling

Conditions: Hyperinsulinism; PCOS; Hyperandrogenism; Metabolic Syndrome

Treatments: Other: Lifestyle modification; Drug: Oral contraceptive; Drug: GLP-1 receptor agonist; Drug: Metformin

Study type: Observational

Funder types: Other

Identifiers

NCT06889454

PCOS_OGTT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 4 patient groups

GLP-1 agonists

Description:

30 women will receive lifestyle modification and GLP-1RA.

Treatment:

Drug: GLP-1 receptor agonist

Oral contraceprives

Description:

30 women will receive lifestyle modification and OCP.

Treatment:

Drug: Oral contraceptive

Metformin

Description:

30 women will receive lifestyle modification and metformin

Treatment:

Drug: Metformin

Lifestyle Modification

Description:

30 women will receive only lifestyle modification

Treatment:

Other: Lifestyle modification