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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLP-1 agonists | 30 women will receive lifestyle modification and GLP-1RA. |
| |
| Oral contraceprives | 30 women will receive lifestyle modification and OCP. |
| |
| Metformin | 30 women will receive lifestyle modification and metformin |
| |
| Lifestyle Modification | 30 women will receive only lifestyle modification |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLP-1 receptor agonist | Drug | 30 women will receive lifestyle modification and GLP-1 receptor agonists |
|
| Measure | Description | Time Frame |
|---|---|---|
| Τhe change in Global Longitudinal Strain during Oral glucose Tolerance Test | Τhe change in Global Longitudinal Strain at 0 and 120 minute after glucose load | 120 minute of Oral glucose Tolerance Test |
| The change in Pulse Wave Velocity during Oral glucose Tolerance Test | The change in Pulse Wave Velocity at 0 and 120 minute after glucose load | 120minute of Oral glucose Tolerance Test |
| The change in Perfused Boundary Region during Oral glucose Tolerance Test | The change in Perfused Boundary Region at 0 and 120 minute after glucose load | 120minute of Oral glucose Tolerance Test |
| The change in Global Longitudinal Strain | The change in Global Longitudinal Strain 6 months after treatment intervention | six months |
| The change in Pulse Wave Velocity | The change in Pulse Wave Velocity 6 months after treatment intervention | six months |
| The change in Perfused Boundary Region | The change in Perfused Boundary Region 6 months after treatment intervention | six months |
| The change in Metalloproteinase 9 | The change in Metalloproteinase 9 six months after tretament intervention | six months |
| Measure | Description | Time Frame |
|---|---|---|
| Τhe change in Coronary flow reserve during Oral glucose Tolerance Test | Τhe change in Coronary flow reserve at 0 and 120 min after glucose load | 120 min of Oral glucose Tolerance Test |
| Τhe change in Flow mediated Dilation during Oral glucose Tolerance Test |
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Inclusion Criteria:
Age > 16 years old
Diagonis of PCOS according to Rotterdam criteria: presence of two of the three of the following:
Absence of treatment for PCOS the last six months
Patients who have the ability to understand and sign the consent form.
Exclusion Criteria:
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Women with PCOS
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| VAIA lAMBADIARI, Professor | Contact | 2105831148 | vlambad@otenet.gr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Attikon University General Hospital | Recruiting | Chaïdári | 124 62 | Greece |
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| Oral contraceptive | Drug | 30 women will receive lifestyle modification and oral contraceptive |
|
| Metformin | Drug | 30 women will receive lifestyle modification and metformin |
|
| Lifestyle modification | Other | 30 women will receive only lifestyle modification |
|
Τhe change in Flow mediated Dilation at 0 and 120 min after glucose load |
| 120min of Oral glucose Tolerance Test |
| The change in Coronary flow reserve | The change in Coronary flow reserve 6 months after treatment intervention | six months |
| The change in Flow mediated Dilation | The change in Flow mediated Dilation 6 months after treatment intervention | six months |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D017588 | Hyperandrogenism |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D058489 | 46, XX Disorders of Sex Development |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D047808 | Adrenogenital Syndrome |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D007333 | Insulin Resistance |
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| ID | Term |
|---|---|
| D003276 | Contraceptives, Oral |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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