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.
Conditions
Interventions
Trade Name: Metformin
Pharmaceutical Form: Tablet
Trade Name: Pioglitazone
Pharmaceutical Form: Tablet
Sponsors
University of Hull
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the cardiovascular risk indices in women with type 2 diabetes with age matched women with PCOS to determine if women with PCOS have the same risk of accelerated atherosclerosis as those with diabetes;Secondary Objective: To determine if the pharmacological effects of metformin and Pioglitazone modify cardiovascular risk and whether that modulation is the same for both type 2 diabetes 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. | — |
Countries
United Kingdom
Outcome results
None listed