Study to Determine if The Cardiovascular risk indices in Type 2 diabetes are similar for Polycystic Ovarian Syndrome, and whether they may be modified by Therapy - Cardiovascular risk in PCOS as compared to type 2 Diabetes

niversity of Hull0 sites48 target enrollmentFebruary 24, 2005

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: This is a randomised parallel controlled trial between patients with type 2 diabetes and those with polycystic ovarian syndrome. Patients will either be randomised to metformin or Pioglitazone.
Sponsor: niversity of Hull
Enrollment: 48
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

February 24, 2005

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

niversity of Hull

•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 diabetes:Age 40\-50
•diabetes (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 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