Suppression With Empagliflozin as an Alternative To High-Fat Low-Carbohydrate Diet for Myocardial FDG-PET Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Levels of serum Beta-hydroxybutyrate (BHB) mmol/L
研究概览
简要总结
The overall objective of this study is to assess if the empagliflozin has the potential to substitute the high fat low carb (HFLC) diet for the preparation of cardiovascular FDG-PET studies.
详细描述
The overall objective of this study is to assess if the SGLT2 inhibitor empagliflozin has the potential to substitute the high fat low carb (HFLC) diet for the preparation of cardiovascular FDG-PET studies. This study will evaluate if an acute administration of empagliflozin (tablets of 10 and/or 25 mg) combined with fasting can sufficiently increase the BHB levels, a proxy of myocardial FDG uptake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 70 years
- •Ability to follow the HFLC diet
- •Ability to provide informed consent
排除标准
- •Treated with SGLT2 inhibitors
- •History of hypersensitivity or allergy to empagliflozin
- •Hypotension with blood pressure <100/65 mmHg
- •Strict vegan
- •Breastfeeding
- •Type I or type II diabetes
- •Renal failure with Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.72m2
- •Receiving steroids
- •History of diabetic ketoacidosis (DKA)
- •History of hypoglycemia
- •Any condition that, in the opinion of the investigator, could compromise the participation in the study
结局指标
主要结局
Levels of serum Beta-hydroxybutyrate (BHB) mmol/L
时间窗: 1 day
Average differences in serum levels of BHB measured following a fast and administration of empagliflozin versus following a fast preceded by a HFLC diet
次要结局
- Proportions of serum Beta-hydroxybutyrate (BHB) >0.5 mmol/L(1 day)
- Proportions of glycemia levels (mmol/L) <3.5 mmol/L(1 day)
- Acceptability and tolerance of each protocol, as reported by patients by a dedicated survey.(Through study completion, up to 3 months.)
研究者
Matthieu Pelletier-Galarneau, MD MSc
Chief, division of nuclear medicine at Institut de cardiologie de Montreal
Montreal Heart Institute