An observational study in PCOS, Hyperinsulinism and Hyperandrogenism, sponsored by Attikon Hospital. Recruiting at 1 site in Greece. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-11-19.
Sponsored by Attikon Hospital · Observational
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.
2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.
This study's planned enrollment of 120 is below the median of 197 across 496 observational studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →Attikon Hospital is the lead sponsor of 86 studies on the registry; 17 are open to participants now.
Compared within Metabolic Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hyperinsulinism. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Women with PCOS
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagonis of PCOS according to Rotterdam criteria: presence of two of the three of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
30 women will receive lifestyle modification and GLP-1RA.
Drug: GLP-1 receptor agonist
30 women will receive lifestyle modification and OCP.
Drug: Oral contraceptive
30 women will receive lifestyle modification and metformin
Drug: Metformin
30 women will receive only lifestyle modification
Other: Lifestyle modification
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
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
Time frame: 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
Time frame: 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
Time frame: 120minute of Oral glucose Tolerance Test
The change in Global Longitudinal Strain
The change in Global Longitudinal Strain 6 months after treatment intervention
Time frame: six months
The change in Pulse Wave Velocity
The change in Pulse Wave Velocity 6 months after treatment intervention
Time frame: six months
The change in Perfused Boundary Region
The change in Perfused Boundary Region 6 months after treatment intervention
Time frame: six months
The change in Metalloproteinase 9
The change in Metalloproteinase 9 six months after tretament intervention
Time frame: six months
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
Time frame: 120 min of Oral glucose Tolerance Test
Τhe change in Flow mediated Dilation during Oral glucose Tolerance Test
Τhe change in Flow mediated Dilation at 0 and 120 min after glucose load
Time frame: 120min of Oral glucose Tolerance Test
The change in Coronary flow reserve
The change in Coronary flow reserve 6 months after treatment intervention
Time frame: six months
The change in Flow mediated Dilation
The change in Flow mediated Dilation 6 months after treatment intervention
Time frame: six months
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Feb 2024 to primary completion in Feb 2025, 12 months.
Of 149 non-industry observational studies under Metabolic Syndrome, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 106. This study's 12 months is below that.
Counting every sponsor, half of 160 studies reached it within 42 months; a quarter within 18 and three quarters within 106.
How these figures are worked out, and which studies are left out of them.
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Attikon Hospital