The LIPT-Study: On Risk Markers of Vascular Thrombosis in Polycystic Ovary Syndrome. A Randomized, Double-Blind, Placebo-Controlled Study of the Effect of Liraglutide

Overweight and insulin resistance (IR) are central pathogenic features of the Polycystic Ovary Syndrome
(PCOS), and weight loss is the main treatment option. PCOS is also associated with signs of a chronic inflammation,
activation of the coagulation system, defect endothelial function and increased arterial stiffness, all regarded as risk
factors or markers for the development of cardiovascular disease. These factors are not taken into account in the
definition of the syndrome, which is based on the 3 Rotterdam criteria. An uncertainty of the clinical risk of
cardiovascular disease (CVD) in these relatively young women has led to many studies on surrogate markers of
CVD in PCOS, including the search for new markers with additional information of the arteriosclerotic burden in
PCOS. GLP-1 analogues, originally developed for the treatment of diabetes, induce weight loss also in non-diabetic
people. We therefore questioned whether treatment with the GLP-1 analogue Liraglutide to women with PCOS in
doses used for diabetes could induce weight loss and improve IR and through this action, or independently, improve
markers of vascular thrombosis in women with PCOS. Thus, 70 overweight and/or insulin resistant PCOS women
were planned treated for 26 weeks in a placebo controlled randomized trial with the following effect parameters to be
evaluated: Changes in Thrombin generation time, Adrenomedullin, Atrial natriuretic peptide, body fat composition
(DEXA), liver fat content (MRI), BMI, IR, sex hormones and ovarian morphology. The protocol and the background
for the study are brought in this report.