PCOSNCT06889454
Cardiovascular and Endothelial Markers During OGTT Before and at Six and Twelve Months Post-treatment in Women With PCOS
An observational study of PCOS and Hyperinsulinism, run by Attikon Hospital at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- PCOS, Hyperinsulinism, Hyperandrogenism
- What is being tested?
- GLP-1 receptor agonist, Oral contraceptive and Metformin
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- 1 siteGreece
- Study dates
- 1 Feb 2024to 1 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with PCOS
Who may be able to join
- Age > 16 years old
- 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)
- Absence of treatment for PCOS the last six months
- Patients who have the ability to understand and sign the consent form.
Who cannot join
- 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
- Treatment with contraceptive or metformin
- Type 2 diabetes mellitus
- Treatment for diabetes
- Pregnancy
- Lactation
- Malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Attikon University General Hospital
Chaïdári, 124 62
Vaia Lambadiari, Professor, 2105831148, vlambad@otenet.gr
About this study
Official title: 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
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.
Read the 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.
- Conditions
- PCOS, Hyperinsulinism, Hyperandrogenism, Metabolic Syndrome
- Being tested
- GLP-1 receptor agonist, Oral contraceptive, Metformin, Lifestyle modification
- Medical subject headings
- Hyperinsulinism, Hyperandrogenism, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1 receptor agonistDrug
30 women will receive lifestyle modification and GLP-1 receptor agonists
Oral contraceptiveDrug
30 women will receive lifestyle modification and oral contraceptive
MetforminDrug
30 women will receive lifestyle modification and metformin
Lifestyle modificationOther
30 women will receive only lifestyle modification
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 agonists | 30 women will receive lifestyle modification and GLP-1RA. Receives: Drug: GLP-1 receptor agonist | |
| Oral contraceprives | 30 women will receive lifestyle modification and OCP. Receives: Drug: Oral contraceptive | |
| Metformin | 30 women will receive lifestyle modification and metformin Receives: Drug: Metformin | |
| Lifestyle Modification | 30 women will receive only lifestyle modification Receives: Other: Lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 120minute of Oral glucose Tolerance Test
The change in Global Longitudinal Strain
The change in Global Longitudinal Strain 6 months after treatment intervention
Measured: six months
The change in Pulse Wave Velocity
The change in Pulse Wave Velocity 6 months after treatment intervention
Measured: six months
The change in Perfused Boundary Region
The change in Perfused Boundary Region 6 months after treatment intervention
Measured: six months
The change in Metalloproteinase 9
The change in Metalloproteinase 9 six months after tretament intervention
Measured: six months
Secondary outcomes (4)
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
Measured: 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
Measured: 120min of Oral glucose Tolerance Test
The change in Coronary flow reserve
The change in Coronary flow reserve 6 months after treatment intervention
Measured: six months
The change in Flow mediated Dilation
The change in Flow mediated Dilation 6 months after treatment intervention
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Feb 2024
- Primary completion1 Feb 2025
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, VAIA LAMBADIARI, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889454
- Sponsor's protocol ID
- PCOS_OGTT
- Status last verified
- Nov 2025
- First submitted
- 16 Mar 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06889454
- Acronym / sponsor ID
- PCOS_OGTT
- Conditions
- PCOS, Hyperinsulinism, Hyperandrogenism, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GLP-1 agonists | – | Drug: GLP-1 receptor agonist30 women will receive lifestyle modification and GLP-1RA. |
| Oral contraceprives | – | Drug: Oral contraceptive30 women will receive lifestyle modification and OCP. |
| Metformin | – | Drug: Metformin30 women will receive lifestyle modification and metformin |
| Lifestyle Modification | – | Other: Lifestyle modification30 women will receive only lifestyle modification |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with PCOS
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
- Treatment with contraceptive or metformin
- Type 2 diabetes mellitus
- Treatment for diabetes
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLP-1 receptor agonist30 women will receive lifestyle modification and GLP-1 receptor agonists | Drug | GLP-1 agonists |
| Oral contraceptive30 women will receive lifestyle modification and oral contraceptive | Drug | Oral contraceprives |
| Metformin30 women will receive lifestyle modification and metformin | Drug | Metformin |
| Lifestyle modification30 women will receive only lifestyle modification | Other | Lifestyle Modification |
Primary outcome
Τhe change in Global Longitudinal Strain during Oral glucose Tolerance Test
Time frame: 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
Time frame: 120minute of Oral glucose Tolerance Test
The change in Pulse Wave Velocity at 0 and 120 minute after glucose load
The change in Perfused Boundary Region during Oral glucose Tolerance Test
Time frame: 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
Time frame: six months
The change in Global Longitudinal Strain 6 months after treatment intervention
The change in Pulse Wave Velocity
Time frame: six months
The change in Pulse Wave Velocity 6 months after treatment intervention
The change in Perfused Boundary Region
Time frame: six months
The change in Perfused Boundary Region 6 months after treatment intervention
The change in Metalloproteinase 9
Time frame: six months
The change in Metalloproteinase 9 six months after tretament intervention
4 secondary outcomes
Τhe change in Coronary flow reserve during Oral glucose Tolerance Test
Time frame: 120 min of Oral glucose Tolerance Test
Τhe change in Flow mediated Dilation during Oral glucose Tolerance Test
Time frame: 120min of Oral glucose Tolerance Test
The change in Coronary flow reserve
Time frame: six months
The change in Flow mediated Dilation
Time frame: six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: Undecided
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PCOS and Hyperinsulinism, run by Attikon Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact VAIA lAMBADIARI, Professor (2105831148, vlambad@otenet.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Τhe change in Global Longitudinal Strain during Oral glucose Tolerance Test (time frame: 120 minute of Oral glucose Tolerance Test). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.