Effect of Luseogliflozin on Myocardial Flow Reserve in Patients with Type 2 Diabetes Mellitus (LUCENT-J Study)

IF 3.8 3区医学 Q2 Medicine

Diabetes Therapy Pub Date : 2024-04-04 DOI:10.1007/s13300-024-01571-0

Tamiko Tamanaha, Hisashi Makino, Cheol Son, Ryo Koezuka, Mayu Tochiya, Yoko Omura-Ohata, Tatsuya Takekawa, Masaki Matsubara, Michio Noguchi, Tsutomu Tomita, Kyoko Honda-Kohmo, Miki Matsuo, Emi Tateishi, Tetsuya Fukuda, Yoshihiro Miyamoto, Satoshi Yasuda, Kiminori Hosoda

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Abstract

Introduction

In patients with type 2 diabetes (T2D), treatment with sodium–glucose cotransporter-2 (SGLT2) inhibitors has been shown to reduce hospital admission rates for heart failure (HF). However, the multiple mechanisms hypothesized and investigated to explain the cardioprotection of SGLT2 inhibitors are not fully understood.

Objectives

The effect of luseogliflozin on myocardial flow reserve (MFR) in patients with T2D (LUCENT-J) study aims to examine the effects of SGLT2 inhibitors on myocardial perfusion.

Methods

The LUCENT-J study is a prospective, single-center, randomized, two-arm, parallel-group, open-label (i.e., the radiology readers are blinded), active-controlled study. A cohort of 40 patients with T2D with no or stable (with no history of myocardial infarction and with or without previous percutaneous coronary intervention) coronary artery disease will be included. Patients will be randomized in a 1:1 ratio to luseogliflozin or control and treated for 24 weeks. The primary outcome is the change in MFR, as measured by ¹³N-ammonia positron emission tomography/computed tomography, from baseline to 24 weeks after treatment initiation.

Planned Outcomes

The LUCENT-J study will elucidate the mechanisms of cardioprotection by SGLT2 inhibitors in patients with T2D.

Trial Registration

Japan Registry of Clinical Trials (JRCTs051220016).

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卢塞格列净对 2 型糖尿病患者心肌血流储备的影响（LUCENT-J 研究）

导言在2型糖尿病（T2D）患者中，钠-葡萄糖共转运体-2（SGLT2）抑制剂的治疗已被证明可降低心力衰竭（HF）的入院率。然而，人们对 SGLT2 抑制剂心脏保护作用的多种机制的假设和研究还不完全清楚。目的Luseogliflozin 对 T2D 患者心肌血流储备（MFR）的影响（LUCENT-J）研究旨在探讨 SGLT2 抑制剂对心肌灌注的影响、即放射科读片人员是盲人）、主动对照研究。研究将纳入 40 名无冠状动脉疾病或病情稳定（无心肌梗死病史，既往接受过或未接受过经皮冠状动脉介入治疗）的 T2D 患者。患者将按 1:1 的比例随机接受 luseogliflozin 或对照组治疗，疗程为 24 周。计划结果LUCENT-J研究将阐明SGLT2抑制剂对T2D患者心脏保护的机制。试验注册日本临床试验注册中心（JRCTs051220016）。

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来源期刊

Diabetes Therapy Medicine-Endocrinology, Diabetes and Metabolism

CiteScore

6.90

自引率

7.90%

发文量

130

审稿时长

6 weeks

期刊介绍： Diabetes Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all areas of diabetes. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Diabetes Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.