Does Co-administration of Lactate Affect Postprandial Nutrient Absorption and Fat Disposition?

NCT06668714 | Recruiting

• 1 other identifier: LAMETA-PET
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Aim To investigate the effects of oral lactate administration on nutrient absorption and substrate utilization in individuals with pre-diabetes. Hypothesis The addition of lactate to a meal improves postprandial lipemia and reduces lipid storage in ectopic tissues through delayed absorption and faster removal of circulating lipids from circulation.

Conditions

Pre Diabetes; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Difference in meal fat uptake in heart tissue between CTR and LAC following a liquid test meal

  The investigators will use a dynamic whole-body PET scan to determine dietary fatty acid trapping and distribution by measuring available 18F-FTHA-tracer in blood coupled with measurement of radioactivity in different organs. The investigators will also use the 18F-FTHA standardized uptake value (SUV) to evaluate dietary fatty acid trapping and distribution, to be able to compare our results with former studies using the 18F-FTHA method.

  5-6 hours

Secondary Outcomes (4)

• Difference in meal fat uptake in skeletal muscle, liver, subcutaneous fat, heart and visceral fat

  7 hours

• Difference in absorption rate and distribution of free fatty acids.

  7 hours

• Difference in subjective appetite sensation

  7 hours

• Difference in ventricular emptying rate

  7 hours

Study Arms (3)

Placebo pre-diabetes

PLACEBO COMPARATOR

Combination Product: Placebo + mixed meal; Combination Product: Lactate + mixed meal; Radiation: PET-scan

Lactate pre-diabetes

EXPERIMENTAL

Combination Product: Placebo + mixed meal; Combination Product: Lactate + mixed meal; Radiation: PET-scan

Healthy

ACTIVE COMPARATOR

We will include 8 healthy, normal-weight individuals (BMI 20-25 kg/m2, age 50+ years) as a healthy control group, who will be studied twice following ingestion of a liquid test meal to determine the differences in meal fat partitioning between insulin-sensitive and insulin-resistant individuals and to determine the intraindividual variation in meal fat partitioning. Furthermore, the extra PET scans performed in the healthy individuals will be used for precise quantification of the radiation exposure with the PET method (dosimetry) and validation of the PET method.

Radiation: PET-scan; Combination Product: Mixed meal with 18F-FTHA

Interventions

Placebo + mixed meal COMBINATION_PRODUCT

Placebo (140 mL isoosmotic salt water, NaCl) given 30 minutes before a liquid test meal with the addition of 70 MBq 18F-FTHA = CTR

Lactate pre-diabetes; Placebo pre-diabetes

Lactate + mixed meal COMBINATION_PRODUCT

Lactate (140 mL lactate drink = 25 g D/L-lactate bound to Na) given 30 minutes before a liquid test meal with the addition of 70 MBq 18F-FTHA = LAC The investigators will also use the 18F-FTHA standardized uptake value (SUV) to evaluate dietary fatty acid trapping and distribution, to be able to compare our results with former studies using the 18F-FTHA method.

Lactate pre-diabetes; Placebo pre-diabetes

PET-scan RADIATION

Dynamic whole-body PET scan.

Healthy; Lactate pre-diabetes; Placebo pre-diabetes

Mixed meal with 18F-FTHA COMBINATION_PRODUCT

Mixed meal test with the addition of 70 MBq 18F-FTHA

Healthy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years
• Written and oral consent
• HbA1c 39-47 mmol/L

You may not qualify if:

• Medicine with an impact on blood glucose and glucose metabolism.
• Affected screening blood sample as evaluated by PI
• Hba1c \> 47
• Allergy to paracetamol
• Doesn't speak or understand Danish
• Special diets
• The eight healthy individuals will be included by the same criteria except for not having pre-diabetes

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Glucose Intolerance; Metabolic Syndrome

Interventions

Lactic Acid; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Insulin Resistance; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Lactates; Hydroxy Acids; Carboxylic Acids; Organic Chemicals; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Esben Søndergaard

  Aarhus University, Steno Diabetes Center Aarhus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natasa B Zubanovic, Medical Doctor

CONTACT

004561698000; natasa.bz@clin.au.dk

Esben Søndergaard, M.D, Associate Professor

CONTACT

esben.sondergaard@clin.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: October 31, 2024
• Study Start: August 22, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

DK (1)