Hyperandrogenism, Hyperinsulinism, Metabolic Syndrome, PCOS
Conditions
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.
Interventions
DRUGGLP-1 receptor agonist
30 women will receive lifestyle modification and GLP-1 receptor agonists
DRUGOral contraceptive
30 women will receive lifestyle modification and oral contraceptive
DRUGMetformin
30 women will receive lifestyle modification and metformin
OTHERLifestyle modification
30 women will receive only lifestyle modification
Sponsors
Attikon Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in Metalloproteinase 9 | six months | The change in Metalloproteinase 9 six months after tretament intervention |
| The change in Perfused Boundary Region during Oral glucose Tolerance Test | 120minute of Oral glucose Tolerance Test | The change in Perfused Boundary Region at 0 and 120 minute after glucose load |
| The change in Global Longitudinal Strain | six months | The change in Global Longitudinal Strain 6 months after treatment intervention |
| The change in Pulse Wave Velocity | six months | The change in Pulse Wave Velocity 6 months after treatment intervention |
| The change in Perfused Boundary Region | six months | The change in Perfused Boundary Region 6 months after treatment intervention |
| Τhe change in Global Longitudinal Strain during Oral glucose Tolerance Test | 120 minute of Oral glucose Tolerance Test | Τhe change in Global Longitudinal Strain at 0 and 120 minute after glucose load |
| The change in Pulse Wave Velocity during Oral glucose Tolerance Test | 120minute of Oral glucose Tolerance Test | The change in Pulse Wave Velocity at 0 and 120 minute after glucose load |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change in Flow mediated Dilation | six months | The change in Flow mediated Dilation 6 months after treatment intervention |
| Τhe change in Coronary flow reserve during Oral glucose Tolerance Test | 120 min of Oral glucose Tolerance Test | Τhe change in Coronary flow reserve at 0 and 120 min after glucose load |
| Τhe change in Flow mediated Dilation during Oral glucose Tolerance Test | 120min of Oral glucose Tolerance Test | Τhe change in Flow mediated Dilation at 0 and 120 min after glucose load |
| The change in Coronary flow reserve | six months | The change in Coronary flow reserve 6 months after treatment intervention |
Countries
Greece
Contacts
Primary ContactVAIA lAMBADIARI, Professor
Outcome results
None listed