A Randomised, Double-blind, Placebo-controlled Study of the Effect of Liraglutide in Polycystic Ovary Syndrome on Risk Markers of Vascular Thrombosis.
Overview
- Phase
- Phase 4
- Intervention
- Liraglutide for 26 weeks
- Conditions
- Polycystic Ovary Syndrome
- Sponsor
- Jens Faber
- Enrollment
- 72
- Locations
- 3
- Primary Endpoint
- Change in Endogenous Thrombin Potential (ETP)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Polycystic ovary syndrome (PCOS) affects 5-10% of women in fertile age. PCOS is associated with metabolic syndrom, diabetes and and increased risk og cardiovascular disease.
The study investigates the effect af intervention with GLP-1-analog on risk markers of cardiovascular disease in women with PCOS.
70 women will be included in af RCT.
Hypothesis: GLP-1-analog treatment in women with PCOS (without diabetes) will result in a beneficial reduction in risk markers of vascular thrombosis and early cardiovascular disease.
Investigators
Jens Faber
Professor, DSc, Senior Hospital Physician
Herlev Hospital
Eligibility Criteria
Inclusion Criteria
- •\>18 years
- •premenopausal
- •BMI \>25 og 25 and thereunder + insulin resistent
- •Exclusion Criteria (including):
- •actualt or intended pregnancy
- •inadeqvat contraception
- •hormonal contraception within 6 weeks
- •metfoomin, GLP-1-analog or DPP IV inhibitor within 3 months
- •medications affectiv hemostatic mechanisme
- •diabetes or other severe comorbidity
Exclusion Criteria
- Not provided
Arms & Interventions
Active
Liraglutide s.c. 1,8mg daily for 26 weeks
Intervention: Liraglutide for 26 weeks
Placebo
Placebo s.c. daily for 26 weeks
Intervention: placebo
Outcomes
Primary Outcomes
Change in Endogenous Thrombin Potential (ETP)
Time Frame: at time 0 and 26 weeks
Area under curve in a Thrombin Generation Test (TGT). Measurements every min for 10 min
Secondary Outcomes
- Percent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1(at time 0 and 26 weeks)