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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2026-02-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hyperinsulinism Hyperandrogenism Metabolic Syndrome PCOS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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GLP-1 agonists

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

GLP-1 receptor agonist

Intervention Type DRUG

30 women will receive lifestyle modification and GLP-1 receptor agonists

Oral contraceprives

30 women will receive lifestyle modification and OCP.

Oral contraceptive

Intervention Type DRUG

30 women will receive lifestyle modification and oral contraceptive

Metformin

30 women will receive lifestyle modification and metformin

Metformin

Intervention Type DRUG

30 women will receive lifestyle modification and metformin

Lifestyle Modification

30 women will receive only lifestyle modification

Lifestyle modification

Intervention Type OTHER

30 women will receive only lifestyle modification

Interventions

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GLP-1 receptor agonist

30 women will receive lifestyle modification and GLP-1 receptor agonists

Intervention Type DRUG

Oral contraceptive

30 women will receive lifestyle modification and oral contraceptive

Intervention Type DRUG

Metformin

30 women will receive lifestyle modification and metformin

Intervention Type DRUG

Lifestyle modification

30 women will receive only lifestyle modification

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No