Does Co-administration of Lactate to an Oral Glucose Tolerance Test Lower the Glucose Response?

NCT06265337 | Completed

• 1 other identifier: LAMETA-OGTT
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate whether co-administration of lactate with a glucose load affects postprandial glucose levels/handling, gastrointestinal hormones, gastric emptying, and appetite sensations in individuals with pre-diabetes when compared to placebo. Hypothesis: Oral lactate administration improves/lowers glucose excursions following an oral glucose tolerance test (OGTT) by stimulating insulin secretion and delaying glucose absorption.

Conditions

PreDiabetes; Metabolic Syndrome; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Difference in integrated glucose concentrations between CTR and LAC following an OGTT

  0-240 minutes after the OGTT

Secondary Outcomes (7)

• Difference in glucose absorption

  0-240 minutes after the OGTT

• Difference in insulin sensitivity

  0-240 minutes after the OGTT

• Difference in insulin secretion

  0-240 minutes

• Difference in free fatty acids concentration

  0-240 minutes after the OGTT

• Difference in ventricular emptying rate

  0-240 minutes after the OGTT

Study Arms (2)

LAC

EXPERIMENTAL

Dietary Supplement: Lactate; Other: Placebo

CTR

PLACEBO COMPARATOR

Dietary Supplement: Lactate; Other: Placebo

Interventions

Lactate DIETARY_SUPPLEMENT

Lactate in an OGTT (300 mL lactate drink = 25 g D/L-lactate bound to Na) =LAC with a stable isotope glucose tracer (D2-glucose) added to measure glucose.

CTR; LAC

Placebo OTHER

Placebo in an OGTT (300 mL salt water, NaCl) =CTR with a stable isotope glucose tracer (D2-glucose) added to measure glucose.

CTR; LAC

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>40 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Steno Diabetes Centre, Aarhus University Hospital

Aarhus, Central Jutland, 8200, Denmark

Location

MeSH Terms

Conditions

Prediabetic State; Metabolic Syndrome; Insulin Resistance

Interventions

Lactic Acid

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Lactates; Hydroxy Acids; Carboxylic Acids; Organic Chemicals

Study Officials

• Esben Søndergaard

  Aarhus University, Steno Diabetes Center Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, M.D, Phd-student

Model Details: In a randomized, double-blinded, placebo-controlled crossover trial, we will investigate the effect of addition of 25 g lactate vs. placebo to an OGTT on two trial days separated by a minimum of fourteen days and a maximum of one month. We will include 12 individuals with pre-diabetes \[9\], having HbA1c 39-47 mmol/L and being above 40 years of age.

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 20, 2024
• Study Start: April 11, 2024
• Primary Completion: August 29, 2024
• Study Completion: September 15, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-02

Locations

DK (1)