Cardiovascular and Endothelial Markers During OGTT Before and at Six and Twelve Months Post-treatment in Women With PCOS

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.

Study Overview

• Status: Recruiting
• Conditions: Hyperandrogenism; Metabolic Syndrome; Hyperinsulinism; PCOS
• Intervention / Treatment: Drug: GLP-1 receptor agonist; Drug: Oral contraceptive; Drug: Metformin; Other: Lifestyle modification

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Vaia Lambadiari, Professor; Phone Number: 2105831148; Email: vlambad@otenet.gr

Study Locations

• Greece
  • Chaïdári, Greece, 124 62
    • Recruiting
    • Attikon University General Hospital
    • Contact: Vaia Lambadiari, Professor; Phone Number: 2105831148; Email: vlambad@otenet.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Women with PCOS

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GLP-1 agonists; 30 women will receive lifestyle modification and GLP-1RA.	Drug: GLP-1 receptor agonist; 30 women will receive lifestyle modification and GLP-1 receptor agonists
Oral contraceprives; 30 women will receive lifestyle modification and OCP.	Drug: Oral contraceptive; 30 women will receive lifestyle modification and oral contraceptive
Metformin; 30 women will receive lifestyle modification and metformin	Drug: Metformin; 30 women will receive lifestyle modification and metformin
Lifestyle Modification; 30 women will receive only lifestyle modification	Other: Lifestyle modification; 30 women will receive only lifestyle modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in Metalloproteinase 9	The change in Metalloproteinase 9 six months after tretament intervention	six months
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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Attikon Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): February 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: March 16, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 21, 2025

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 15, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Glucose Metabolism Disorders; Gonadal Disorders; Congenital Abnormalities; Insulin Resistance; Disorders of Sex Development; Urogenital Abnormalities; 46, XX Disorders of Sex Development; Adrenogenital Syndrome; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Metabolic Syndrome; Hyperinsulinism; Hyperandrogenism; Physiological Effects of Drugs; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptive Agents; Organic Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Biguanides; Guanidines; Amidines; Metformin; Contraceptives, Oral
• Other Study ID Numbers: PCOS_OGTT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No