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
Open accessAbstract
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.
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A power analysis for the secondary endpoint MR-proADM indicated that with a sample size of 42:21, an in-house s.d. of 0.03 nmol/L and a two-sided significance level of 5%, the study could detect a change in MR-proADM of 0.025 nmol/L (approximately 5% of baseline) with 90% power.
“A power analysis of the secondary endpoint MR-proADM was performed before randomization as described (25). With a sample size of 42:21 (liraglutide:placebo), an in-house s.d. of 0.03 nmol/L and a two-sided significance level of 5%, we were able to detect a change in MR-proADM of 0.025 nmol/L (equal to approximately 5% of the baseline values) with a power of 90%.”
From Effect of liraglutide on atrial natriuretic peptide, adrenomedullin, and copeptin in PCOS (2018) · cites this paper as [25]
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Self-citationEffect of liraglutide on atrial natriuretic peptide, adrenomedullin, and copeptin in PCOS
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Polycystic Ovarian Syndrome: An Unsolved WomenâÂÂs Health Disorder
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- Authors
- Malin Nylander, S. F.
- Venue
- Journal of Obesity & Weight Loss Therapy
- Publisher
- OMICS Publishing Group
- Published
- 2015
- Volume
- 05
- Issue
- 02
- ISSN
- 2165-7904 (ISSN-L)
- OpenAlex
- W2481340408
- Cited by
- 7
- References
- 34
- Citations by year
- 2018: 1 · 2017: 3 · 2016: 3
- FWCI
- 2.67
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by
- Locations
- Journal of Obesity & Weight loss Therapy (publishedVersion, cc-by)
- Topics
- Health Sciences › Medicine › Reproductive Medicine › Ovarian function and disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Health Sciences › Medicine › Neurology › Cerebral Venous Sinus Thrombosis
- Keywords
- polycystic ovary syndrome, liraglutide, GLP-1 receptor agonists, insulin resistance, weight loss, cardiovascular risk markers, vascular thrombosis, thrombin generation, adrenomedullin, atrial natriuretic peptide, endothelial function, arterial stiffness, overweight women, liver fat, sex hormones
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