Attikon University General Hospital
Chaïdári, 124 62, Greece
Location status: Recruiting
NCT Number: NCT06889454
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.
Interested in participating?
Request Info18 year–45 year
Female
Observational
Chaïdári, 124 62, Greece
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
30 women will receive lifestyle modification and GLP-1 receptor agonists
30 women will receive lifestyle modification and oral contraceptive
30 women will receive lifestyle modification and metformin
30 women will receive only lifestyle modification
Time frame: 120 minute of Oral glucose Tolerance Test
Τhe change in Global Longitudinal Strain at 0 and 120 minute after glucose load
Time frame: 120minute of Oral glucose Tolerance Test
The change in Pulse Wave Velocity at 0 and 120 minute after glucose load
Time frame: 120minute of Oral glucose Tolerance Test
The change in Perfused Boundary Region at 0 and 120 minute after glucose load
Time frame: six months
The change in Global Longitudinal Strain 6 months after treatment intervention
Time frame: six months
The change in Pulse Wave Velocity 6 months after treatment intervention
Time frame: six months
The change in Perfused Boundary Region 6 months after treatment intervention
Time frame: six months
The change in Metalloproteinase 9 six months after tretament intervention
Time frame: 120 min of Oral glucose Tolerance Test
Τhe change in Coronary flow reserve at 0 and 120 min after glucose load
Time frame: 120min of Oral glucose Tolerance Test
Τhe change in Flow mediated Dilation at 0 and 120 min after glucose load
Time frame: six months
The change in Coronary flow reserve 6 months after treatment intervention
Time frame: six months
The change in Flow mediated Dilation 6 months after treatment intervention
Contact information is provided by the study sponsor or research team.
Attikon Hospital
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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