The Lactate Project: Investigating the Impact of Lactate to Preserve Vital Organ Blood Supply and Function in Heart and Brain

NCT06665763 | Not Yet Recruiting

• 1 other identifier: THE LACTATE PROJECT
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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

Conditions

Healthy; Lactate Blood Increase

Keywords

Human metabolism; Substrate utilization; Cerebral blod flow; Cardiac metabolism; Cerebral metabolism; Cardiac perfusion; Glucose metabolism; Lipid metabolism; Lactate utilization

Outcome Measures

Primary Outcomes (1)

• Cerebral glucose uptake

  Cerebral glucose uptake (\[18F\]FDG PET scan) under basal and hyperinsulinemic- euglycemic conditions (clamp conditions).

  From T=300-360 (minutes)

Secondary Outcomes (7)

• 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)

Study Arms (2)

Na-Lactate infusion

EXPERIMENTAL

Other: Sodium Lactate Solution

Saline infusion (Placebo)

PLACEBO COMPARATOR

Other: Saline infusion (placebo)

Interventions

Sodium Lactate Solution OTHER

Infusion of sodium-lactate solution

Na-Lactate infusion

Saline infusion (placebo) OTHER

NaCl solution

Also known as: NaCl

Saline infusion (Placebo)

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 55-75 years
• Male or postmenopausal female
• BMI 20-35 kg/m2
• Signed informed consent form

You may not qualify if:

• 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
• Smoking
• Alcohol- or substance abuse
• Participation in other clinical trials involving ionized radiation within the last 6 months
• Claustrophobia

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (2)

Medical Research Laboratories/Steno Diabetes Center Aarhus

Aarhus, N, 8000, Denmark

Location

Department of Nuclear Medicine & PET-Centre

Aarhus, N, 8200, Denmark

Location

MeSH Terms

Conditions

Hyperlactatemia

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Esben Søndergaard, MD, PhD

CONTACT

004528730943; Esben.sondergaard@clin.au.dk

Jens Voigt, MD

CONTACT

0026395294; Jens.voigt@clin.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be carried out as a single-blinded, randomized cross-over clinical investigational trial.

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 30, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)