Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity in Healthy Subjects
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
- Renal Blood Flow (RBF)
研究概览
简要总结
This is a randomized, placebo-controlled, double-blinded crossover design. Fifteen healthy subjects will be randomized to receive either ketone bodies (KE4) or placebo delivered by KetoneAid. After a period of 5-days treatment, effect variables will be measured (experiment day 1). After a washout period of 14 days, the subjects are crossed over to a similar treatment period with the other treatment. The study is terminated by measuring effect variables after the second treatment period (experiment day 2).
详细描述
Background: Renewed interest in ketone bodies has emerged, partly driven by the recent success of selective sodium glucose co transporter 2 (SGLT-2) inhibition in preventing cardiovascular deaths in patients with diabetes mellitus (DM) and chronic kidney disease (CKD). Effects of ketosis are of importance in order to understand the beneficial effects of SGLT-2 inhibitors and to account for the full therapeutic potential of this treatment.
Hypothesis
Ketosis increases renal blood flow and glomerular filtration rate (GFR).
Methods: It is a randomized, placebo-controlled double-blinded cross over study. Fifteen healthy subjects will be randomized to receive either ketone bodies (KE4) or for 5 days. After a wash out period of at least 14 days, the subjects are crossed over to receive the other treatment. After each treatment period effect variables will be measured including Technetium(Tc)99m - Diethylenetriamine pentaacetate (DTPA) clearance and water based positron emission tomography computed tomography (PET/CT)
Perspectives: The study has the potential to provide information regarding the therapeutic potential of treatment with ketone bodies and understanding of conditions characterized by ketosis, such as SGLT2-inhibitor treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI < 30 kg/m2
- •Safe contraception if women in childbearing age
- •Normal biochemical screening
排除标准
- •Pregnancy or breast feeding
- •Major heart-, liver-, kidney-, lung-, neurological- or endocrine disease
- •Daily use of prescription drugs (expect for contraceptives)
- •Alcohol or drug abuse
- •Periodic fasting
- •Routinely intake of ketogenic diet
结局指标
主要结局
Renal Blood Flow (RBF)
时间窗: Subjects are scanned after each treatment period (day 6 and approximately day 26)
Change in RBF determined by water based PET/CT scans
GFR
时间窗: Measured after each treatment period (day 6 and approximately day 26)
Change in GFR measured by Tc99m-DTPA clearance
次要结局
- 24-hour blood pressure(Measured after each treatment period (day 6 and approximately day 26))
- Vasoactive hormones(Measured after each treatment period (day 6 and approximately day 26))
- Beta-hydroxybutyrate(Measured after each treatment period (day 6 and approximately day 26))
- Renal tubular transport proteins(Measured after each treatment period (day 6 and approximately day 26))