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

ConditionsPCOSHyperinsulinismHyperandrogenismMetabolic Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorAttikon Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 16 years old

Clinical or biochemical hyperandrogenism

Anovulation or oligo-ovulation

Polycystic ovarian morphology (PCOM)

Disqualifiers

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

Trial population

Women with PCOS

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • GLP-1 receptor agonist

    Drug

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

  • Oral contraceptive

    Drug

    30 women will receive lifestyle modification and oral contraceptive

  • Metformin

    Drug

    30 women will receive lifestyle modification and metformin

  • Lifestyle modification

    Other intervention

    30 women will receive only lifestyle modification

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: GLP-1 agonists1 intervention
Group B: Oral contraceprives1 intervention
Group C: Metformin1 intervention
Group D: Lifestyle Modification1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

The change in Global Longitudinal Strain

The change in Global Longitudinal Strain 6 months after treatment intervention

Time frame
six months

Secondary outcomes

1

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
2

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
3

The change in Coronary flow reserve

The change in Coronary flow reserve 6 months after treatment intervention

Time frame
six months
4

The change in Flow mediated Dilation

The change in Flow mediated Dilation 6 months after treatment intervention

Time frame
six months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Attikon Hospital

Lead sponsor

Source ClinicalTrials.gov
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