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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
| Signe Frøssing1, Malin Nylander2, Caroline Kistorp1,3, Sven Skouby2,3 and Jens Faber1,3* | |
| 1Department of Endocrinology and Internal Medicine, Herlev Hospital, Copenhagen Denmark | |
| 2Department of Obstetrics and Gynecology, Reproductive Medicine, Herlev Hospital, Copenhagen, Denmark | |
| 3Faculty of Health and Medical Sciences, University of Copenhagen, Denmark | |
| Corresponding Author : | Signe Frøssing MD, Department of Endocrinology and Internal Medicine Herlev University Hospital, Copenhagen, Herlev Ringvej 75, Dk-2730 Herlev, Denmark Tel: 45 3868 2139 Fax: 45 3868 4101 E-mail: signe.froessing@regionh.dk |
| Received February 16, 2015; Accepted March 14, 2015; Published March 30, 2015 | |
| Citation: Frøssing S, Nylander M, Kistorp C, Skouby S, Faber J (2015) 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. J Obes Weight Loss Ther 5:254. doi:10.4172/2165-7904.1000254 | |
| Copyright: © 2015 Frøssing S, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. | |
Abstract
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.
