Study to Determine if The Cardiovascular risk indices in Impaired Glucose Tolerance are similar for Polycystic Ovarian Syndrome, and whether they may be modified by Therapy - Cardiovascular risk in PCOS as compared to impaired glucose tolerance

Phase 1

• Conditions: This is a randomised parallel controlled trial between patients with impaired glucose tolerance and those with polycystic ovarian syndrome. Patients will either be randomised to metformin or Pioglitazone.

• Registration Number: EUCTR2005-000435-18-GB
• Lead Sponsor: niversity of Hull

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-02-25
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

Inclusion criteria for polycystic ovarian syndrome: Age 40-50.
Polycystic ovarian syndrome (Rotterdam consensus criteria): irregular menses since menarche, oligomenorrhoea, clinical or biochemical hyperandrogenism, polycystic ovaries on ultrasound scanning.

Inclusion criteria for impaired glucose tolerance:Age 40-50
impaired glucose tolerance (diagnosed by WHO criteria)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria for polycystic ovarian syndrome:
Peri-menopausal symptoms,
Patient should not be on any medication, Unwilling for GP to be informed, Impaired glucose tolerance/ diabetes on GTT

Exclusion criteria for impaired glucose tolerance:
Peri-menopausal symptoms, Patient should not be on any medication, Unwilling for GP to be informed, Polycystic ovarian syndrome (patients must have regular periods, no clinical or biochemical evidence of hyperandrogenism, normal ovaries on ultrasound scanning

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the cardiovascular risk indices in women with impaired glucose tolerance with age matched women with PCOS to determine if women with PCOS have the same risk of accelerated atherosclerosis as those with impaired glucose tolerance;Secondary Objective: To determine if the pharmacological effects of metformin and Pioglitazone modify cardiovascular risk and whether that modulation is the same for both impaired glucose tolerance and PCOS.;Primary end point(s): Change in insulin resistance pre and post treatment with metformin or pioglitazone as measured by insulin clamp study and change in endothelial function pre and post treatment as measured by flow-mediated vasoditation.