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Long-term Effects of high-doSe pitavaStatin on Diabetogenicity in comparison with atorvastatin in patients with Metabolic syndrome (LESS-DM): study protocol for a randomized controlled trial
DC Field | Value | Language |
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dc.contributor.author | Park, Jun-Bean | - |
dc.contributor.author | Jung, Ji-Hyun | - |
dc.contributor.author | Yoon, Yeonyee E. | - |
dc.contributor.author | Kim, Hack-Lyong | - |
dc.contributor.author | Lee, Seung-Pyo | - |
dc.contributor.author | Kim, Hyung-Kwan | - |
dc.contributor.author | Kim, Yong-Jin | - |
dc.contributor.author | Cho, Goo-Yeong | - |
dc.contributor.author | Sohn, Dae-Won | - |
dc.date.accessioned | 2017-11-03T06:26:18Z | - |
dc.date.available | 2017-11-03T15:28:34Z | - |
dc.date.issued | 2017-10-27 | - |
dc.identifier.citation | Trials, 18(1):501 | ko_KR |
dc.identifier.issn | 1745-6215 | - |
dc.identifier.uri | https://hdl.handle.net/10371/138335 | - |
dc.description.abstract | Abstract
Background The diabetogenic action of statins remains a concern, particularly in patients at high risk for diabetes receiving intensive statin therapy. Despite the risk of diabetes with statin use being considered a potential class effect, recent studies have suggested that pitavastatin exerts neutral or favorable effects on diabetogenicity. However, no randomized trial has compared the long-term effects of pitavastatin with those of other statins on glycemic control in populations at high risk for diabetes. Hence, we aim to assess the long-term effects of pitavastatin in comparison with atorvastatin on glucose metabolism in patients with metabolic syndrome (MetS). Methods/design The Long-term Effects of high-doSe pitavaStatin on Diabetogenicity in comparison with atorvastatin in patients with Metabolic syndrome (LESS-DM) trial is a prospective, randomized, open-label, active control clinical trial of patients with MetS. We plan to randomize 500 patients with MetS (1:1) to receive high-dose pitavastatin (4mg) or atorvastatin (20mg) daily for 24months. The primary endpoint will be the change in hemoglobin A1c after statin treatment. Secondary endpoints will include the following: (1) changes in biochemical markers, including insulin, C-peptide, homeostasis model assessment of insulin resistance and insulin secretion, and adiponectin; (2) changes in imaging parameters, including carotid elasticity metrics and indices of cardiac function; and (3) the incidence of clinical events, including new-onset diabetes and cardiovascular disease. Discussion In this trial, we will explore whether pitavastatin 4mg does not disturb glucose metabolism in patients with MetS. It will also provide mechanistic information on statin type-dependent diabetogenic effects and surrogate data regarding vascular and cardiac changes achieved by intensive statin therapy. | ko_KR |
dc.description.sponsorship | This study is supported in part by a research grant from JW Pharmaceutical Corporation (Seoul, Republic of Korea). The authors are solely responsible for the study design, conduct of the study, data analyses, and drafting or editing of the manuscript. | ko_KR |
dc.language.iso | en | ko_KR |
dc.publisher | BioMed Central | ko_KR |
dc.subject | Statin | ko_KR |
dc.subject | Glucose metabolism | ko_KR |
dc.subject | Adiponectin | ko_KR |
dc.subject | Carotid elasticity | ko_KR |
dc.subject | Cardiac function | ko_KR |
dc.subject | Metabolic syndrome | ko_KR |
dc.title | Long-term Effects of high-doSe pitavaStatin on Diabetogenicity in comparison with atorvastatin in patients with Metabolic syndrome (LESS-DM): study protocol for a randomized controlled trial | ko_KR |
dc.type | Article | ko_KR |
dc.contributor.AlternativeAuthor | 박준범 | - |
dc.contributor.AlternativeAuthor | 정지현 | - |
dc.contributor.AlternativeAuthor | 윤연이 | - |
dc.contributor.AlternativeAuthor | 김학룡 | - |
dc.contributor.AlternativeAuthor | 이승표 | - |
dc.contributor.AlternativeAuthor | 김형관 | - |
dc.contributor.AlternativeAuthor | 김용진 | - |
dc.contributor.AlternativeAuthor | 조구영 | - |
dc.contributor.AlternativeAuthor | 손대원 | - |
dc.identifier.doi | 10.1186/s13063-017-2229-4 | - |
dc.language.rfc3066 | en | - |
dc.rights.holder | The Author(s). | - |
dc.date.updated | 2017-10-29T12:58:24Z | - |
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