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临床试验/NCT05764811
NCT05764811已完成不适用

Mechanism of the Effect by Sodium-glucose Cotransporter-2 Inhibitor on Obesity Associated Cardiomyopathy

National Cheng-Kung University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年3月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
measure the severity of fatty liver via MRI

研究概览

简要总结

Obesity is closely associated with an increased risk of cardiomyopathy because of the high metabolic activity of excessive fat while effective treatment of obesity-related cardiomyopathy is currently unsolved. Sodium-glucose cotransporter-2 inhibitors (SGLT2-i) are a class of diabetic medications. Besides improving glucose control, SGLT2-i has been shown to be able to reduce the bodyweight as well as the mortality and hospitalization rates for heart failure and cardiovascular disease in the type 2 diabetes patients. It has been proposed that the heart protection by SGLT2-i might be caused by modulating the production of adipokine and cytokine. The investigators will enrolled 40 patients (diabetes mellitus with BMI>27 Kg/m2) from obesity weight-reduction clinics: 1) 20 patients treated with SGLT2-i (CANA) and regular weight-reduction plan; 2) 20 patients with regular weight reduction plan, without CANA, for 4 weeks. The investigators will compare the variation of Fibroblast growth factor-21 (FGF21) related proteins and RNA between these 2 groups of subjects. The investigators will arrange cardiac ultrasound, hepatic MRI and fibroscan, body composition dual energy x-ray absorptiometry to evaluate the possible mechanisms underlying the liver and heart modification process, as a scientific basis for precision medicine in the future. Conclusions: SGLT2-i treatment may increase the concentration of FGF21, either in the liver or heart, thus to protect the high-fat diet induced obesity associated heart dysfunction by activating FGF21 downstream protein expression.

详细描述

The investigators will enrolled 40 diabetes mellitus with BMI>27 Kg/m2 patients from obesity weight-reduction clinics and will compare the variation of FGF21 related proteins between these 2 groups of subjects. Serial examinations will evaluate the possible mechanisms underlying the protective mechanism. This investigation expect that SGLT2-inhibitor can increase the concentration of FGF21 in the heart by increasing FGF21 in the liver, thereby modifying associated protein expressions and ultimately improving cardiac function and patient outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age> 20 years of age
  • With diagnosis of diabetic mellitus (HbA1C≧6.5%) by medical record or physicians
  • BMI ≧ 27 kg/m2, which is the current definition of obesity from Health Promotion Administration, Ministry of Health and Welfare.

排除标准

  • Unwilling to participating current clinical trial
  • Cannot tolerate SGLT2-i therapy
  • Not willing to join the study
  • History of failure treatment experience from SGLT2-i or other weight reduction plan
  • Received pharmaceutical or clinical trials within past 1 year

研究组 & 干预措施

Canagliflozin Treatment

Active Comparator

Use Canagliflozin 100 mg daily, 1 month

干预措施: Canagliflozin 100mg (Drug)

结局指标

主要结局

measure the severity of fatty liver via MRI

时间窗: 4 weeks

The fibrotic score and severity by MRI of the liver will be performed before and after the treatment. The measurement of fatty liver requires both in-phase (IP) and out-of-phase (OOP) imaging to be adequately assessed. Fatty liver appears: T1: hyperintense, T2: mildly hyperintense, IP/OOP imaging: signal drop out on OOP imaging On IP/OOP imaging, signal loss is demonstrated when there is 10-15% fat fraction with maximum signal loss occurring when there is 50% fatty infiltration of the liver. In situations in which there is \>50% fatty infiltration, the out-of-phase sequence paradoxically becomes less hypointense than at 50%.

次要结局

  • measure the body weight before and after the treatment(4 weeks)
  • measure the body height before and after the treatment(4 weeks)
  • measure the body mass index (BMI) before and after the treatment(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ping-Yen Liu

Doctor/Professor

National Cheng-Kung University Hospital

研究点 (1)

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