The Lactate Project: Investigating the Impact of Lactate to Preserve Vital Organ Blood Supply and Function in Heart and Brain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Aarhus
- Enrollment
- 8
- Locations
- 2
- Primary Endpoint
- Cerebral glucose uptake
Study Overview
Brief Summary
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
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 55 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 55-75 years
- •Male or postmenopausal female
- •BMI 20-35 kg/m2
- •Signed informed consent form
Exclusion Criteria
- •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
Arms & Interventions
Saline infusion (Placebo)
Intervention: Saline infusion (placebo) (Other)
Na-Lactate infusion
Intervention: Sodium Lactate Solution (Other)
Outcomes
Primary Outcomes
Cerebral glucose uptake
Time Frame: From T=300-360 (minutes)
Cerebral glucose uptake (\[18F\]FDG PET scan) under basal and hyperinsulinemic- euglycemic conditions (clamp conditions).
Secondary Outcomes
- 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))