The Lactate Project: Investigating the Impact of Lactate to Preserve Vital Organ Blood Supply and Function in Heart and Brain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Cerebral glucose uptake
研究概览
简要总结
The aim of the proposed study is to investigate the effect of increased plasma lactate concentrations on the heart and brain's metabolism of other energy sources, primarily glucose in the brain and glucose and FFA in the heart.
The investigator hypothesize that:
- An acute increase in lactate plasma concentration will decrease cerebral glucose uptake and increase cerebral blood flow
- An acute increase in lactate plasma concentration will decrease palmitate and glucose uptake in the myocardium, and increase myocardial perfusion
详细描述
SCREENING VISIT
During the initial screening visit, the investigators will inform all potential volunteers about the project, and volunteers will have the chance to ask questions about participation in the project.
The investigators will register the following data
- Medical history to assess exclusion criteria
- Weight, height, BMI
- Standard medical examination including pulse, blood pressure and an ECG
After assessment of inclusion- and exclusion criteria remaining volunteers will be offered to participate in the project. The investigators will screen potential volunteers with the following blood samples: haemoglobin, HbA1c, glucose, cholesterol, triglyceride, TSH, creatinine, albumin, sodium, potassium, ALAT, ASAT, bilirubin and coagulation parameters.
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
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 55-75 years
- •Male or postmenopausal female
- •BMI 20-35 kg/m2
- •Signed informed consent form
排除标准
- •Clinically significant heart, lung, kidney, kidney, liver, endocrine or malignant disease basedon information obtained during an initial screening visit as well as blood samples and an ECG.
- •Blood donation within the last 3 months
- •Alcohol- or substance abuse
- •Participation in other clinical trials involving ionized radiation within the last 6 months
- •Claustrophobia
研究组 & 干预措施
Saline infusion (Placebo)
干预措施: Saline infusion (placebo) (Other)
Na-Lactate infusion
干预措施: Sodium Lactate Solution (Other)
结局指标
主要结局
Cerebral glucose uptake
时间窗: From T=300-360 (minutes)
Cerebral glucose uptake (\[18F\]FDG PET scan) under basal and hyperinsulinemic- euglycemic conditions (clamp conditions).
次要结局
- Cerebral blood flow(T = 0-10 (minutes))
- Myocardial perfusion(T = 0-10 (minutes))
- Myocardial glucose uptake(T = 300-360 (minutes))
- Myocardial FFA uptake and oxidation(T = 30-70 (minutes))
- Myocardial contractility(T=0-10 (minutes))
- Myocardial oxygen consumption and efficiency(T=150-180 (minutes))
- Blood sampling(T = -60 to 360 (minutes))