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

NCT06889454 | Recruiting FDA Drug

• 1 other identifier: PCOS_OGTT
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

PCOS; Hyperinsulinism; Hyperandrogenism; Metabolic Syndrome

Outcome Measures

Primary Outcomes (7)

• 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

• The change in Metalloproteinase 9

  The change in Metalloproteinase 9 six months after tretament intervention

  six months

Secondary Outcomes (4)

• Τhe change in Coronary flow reserve during Oral glucose Tolerance Test

  120 min of Oral glucose Tolerance Test

• Τhe change in Flow mediated Dilation during Oral glucose Tolerance Test

  120min of Oral glucose Tolerance Test

• The change in Coronary flow reserve

  six months

• The change in Flow mediated Dilation

  six months

Study Arms (4)

GLP-1 agonists

30 women will receive lifestyle modification and GLP-1RA.

Drug: GLP-1 receptor agonist

Oral contraceprives

30 women will receive lifestyle modification and OCP.

Drug: Oral contraceptive

Metformin

30 women will receive lifestyle modification and metformin

Drug: Metformin

Lifestyle Modification

30 women will receive only lifestyle modification

Other: Lifestyle modification

Interventions

GLP-1 receptor agonist DRUG

30 women will receive lifestyle modification and GLP-1 receptor agonists

GLP-1 agonists

Oral contraceptive DRUG

30 women will receive lifestyle modification and oral contraceptive

Oral contraceprives

Metformin DRUG

30 women will receive lifestyle modification and metformin

Metformin

Lifestyle modification OTHER

30 women will receive only lifestyle modification

Lifestyle Modification

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women with PCOS

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (1)

Attikon University General Hospital

Chaïdári, 124 62, Greece

RECRUITING

MeSH Terms

Conditions

Hyperinsulinism; Hyperandrogenism; Metabolic Syndrome

Interventions

Contraceptives, Oral; Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases; Insulin Resistance

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

VAIA lAMBADIARI, Professor

CONTACT

2105831148; vlambad@otenet.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine-Endocrinology

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: March 21, 2025
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

GR (1)