PreDiabetesNCT06265337
Does Co-administration of Lactate to an Oral Glucose Tolerance Test Lower the Glucose Response?
A study testing Lactate in people with PreDiabetes and Metabolic Syndrome, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes, Metabolic Syndrome, Insulin Resistance
- What is being tested?
- Lactate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Apr 2024to 15 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >40 years
- Written and oral consent
- HbA1c 39-47 mmol/L
Who cannot join
- Medicine with an impact on blood glucose and glucose metabolism
- Newly started medicine (<3 months prior to the inclusion time)
- Medicine changes (<3 months prior to the inclusion time and planned changes during the trial)
- Affected screening blood sample as evaluated by PI
- Hba1c > 47
- Allergy to paracetamol
- Doesn't speak or understand Danish.
- Special diets
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Steno Diabetes Centre, Aarhus University Hospital
Aarhus, Central Jutland, 8200
About this study
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.
Read the detailed description
The participants will be instructed to avoid hard-to-moderate physical activity for 48 hours before each of the two trial days. They will be instructed to eat the same diet 72 hours before the two trial days at the screening visit and to register it in MyFood24 which is an electronic foodlog.
Trial days:
The two trial days will be completely alike, besides the interventions consisting of either:
- Placebo in an OGTT (300 mL salt water, NaCl) =CTR, or
- 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 each of the interventions to measure glucose uptake. 1500 mg of paracetamol will be added to measure ventricular emptying rate using the acetaminophen test.
An H3-glucose tracer will be continuously infused to measure glucose turnover. Glucose tolerance and absorption together with hepatic glucose production and insulin secretion will be quantified using the oral minimal model.
After this, the participant can lie in their bed. Blood samples will be collected continuously during the day. Appetite sensations will be measured by a visual analogue scale (VAS). After 4 hours the trial day is finished, and the participants can go home.
They will be instructed to collect two fecal samples after each of the trial days, which will be analysed for fecal microbiota composition (16S rRNA gene sequencing and quantitative PCR) and fecal fermentation metabolite profiles by our collaborator Clarissa Schwab.
Analyses Blood sample analyses will be made for the concentration of lactate, insulin, GLP-1, GIP, ghrelin, LEAP-2, glucagon, c-peptide, blood glucose, triglycerides, cholesterol, and other relevant metabolites and hormones. Supplementary ventricular emptying rate will be compared between CTR and LAC. [3H ]-glucose-tracer will be infused for six hours (bolus 12 mCi, infusion 0,12 mCi/min) to determine glucose metabolism.
Statistics and power calculation We will use simple paired t-tests and two-way repeated measure ANOVA analyses for comparing the two groups.
Based on a previous study we will need 12 individuals to detect a difference of 15% in integrated glucose concentrations and 40% in disposition index after the OGTT (α=0.05, β=0.80). This is similar to the effect size observed in studies investigating the treatment with a dipeptidyl peptidase-4 inhibitor (a weak insulin secretagogue).
- Conditions
- PreDiabetes, Metabolic Syndrome, Insulin Resistance
- Being tested
- Lactate, Placebo
- Medical subject headings
- Prediabetic State, Metabolic Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactateDietary 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.
PlaceboOther
Placebo in an OGTT (300 mL salt water, NaCl) =CTR with a stable isotope glucose tracer (D2-glucose) added to measure glucose.
| Study group | Role | What they receive |
|---|---|---|
| LAC | Experimental | Not described Receives: Dietary Supplement: Lactate; Other: Placebo |
| CTR | Placebo comparator | Not described Receives: Dietary Supplement: Lactate; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in integrated glucose concentrations between CTR and LAC following an OGTT
Measured: 0-240 minutes after the OGTT
Secondary outcomes (7)
Difference in glucose absorption
Oral minimal model
Measured: 0-240 minutes after the OGTT
Difference in insulin sensitivity
Oral minimal model
Measured: 0-240 minutes after the OGTT
Difference in insulin secretion
Oral minimal model
Measured: 0-240 minutes
Difference in free fatty acids concentration
Measured: 0-240 minutes after the OGTT
Difference in ventricular emptying rate
Acetaminophen test
Measured: 0-240 minutes after the OGTT
Difference in subjective appetite sensation
VAS score
Measured: 0-240 minutes after the intervention
Difference in integrated GLP-1 concentrations
Measured: 0-240 minutes after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start11 Apr 2024
- Primary completion29 Aug 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natasa Brkovic Zubanovic, University of Aarhus
- Investigators
- Esben Søndergaard, Principal investigator, Aarhus University, Steno Diabetes Center Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265337
- Sponsor's protocol ID
- LAMETA-OGTT
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Co-administration of Lactate to an Oral Glucose Tolerance Test Lower the Glucose Response?
- ClinicalTrials.gov ID
- NCT06265337
- Acronym / sponsor ID
- LAMETA-OGTT
- Conditions
- PreDiabetes, Metabolic Syndrome, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The participants will be instructed to avoid hard-to-moderate physical activity for 48 hours before each of the two trial days. They will be instructed to eat the same diet 72 hours before the two trial days at the screening visit and to register it in MyFood24 which is an electronic foodlog.
Trial days:
The two trial days will be completely alike, besides the interventions consisting of either:
- Placebo in an OGTT (300 mL salt water, NaCl) =CTR, or
- 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 each of the interventions to measure glucose uptake. 1500 mg of paracetamol will be added to measure ventricular emptying rate using the acetaminophen test.
An H3-glucose tracer will be continuously infused to measure glucose turnover. Glucose tolerance and absorption together with hepatic glucose production and insulin secretion will be quantified using the oral minimal model.
After this, the participant can lie in their bed. Blood samples will be collected continuously during the day. Appetite sensations will be measured by a visual analogue scale (VAS). After 4 hours the trial day is finished, and the participants can go home.
They will be instructed to collect two fecal samples after each of the trial days, which will be analysed for fecal microbiota composition (16S rRNA gene sequencing and quantitative PCR) and fecal fermentation metabolite profiles by our collaborator Clarissa Schwab.
Analyses Blood sample analyses will be made for the concentration of lactate, insulin, GLP-1, GIP, ghrelin, LEAP-2, glucagon, c-peptide, blood glucose, triglycerides, cholesterol, and other relevant metabolites and hormones. Supplementary ventricular emptying rate will be compared between CTR and LAC. [3H ]-glucose-tracer will be infused for six hours (bolus 12 mCi, infusion 0,12 mCi/min) to determine glucose metabolism.
Statistics and power calculation We will use simple paired t-tests and two-way repeated measure ANOVA analyses for comparing the two groups.
Based on a previous study we will need 12 individuals to detect a difference of 15% in integrated glucose concentrations and 40% in disposition index after the OGTT (α=0.05, β=0.80). This is similar to the effect size observed in studies investigating the treatment with a dipeptidyl peptidase-4 inhibitor (a weak insulin secretagogue).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| LAC | Experimental | Dietary Supplement: Lactate, Other: Placebo |
| CTR | Placebo comparator | Dietary Supplement: Lactate, Other: Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >40 years
Key exclusion criteria (8 listed)
- Medicine with an impact on blood glucose and glucose metabolism
- Newly started medicine (<3 months prior to the inclusion time)
- Medicine changes (<3 months prior to the inclusion time and planned changes during the trial)
- Affected screening blood sample as evaluated by PI
- Hba1c > 47
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LactateLactate 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. | Dietary supplement | CTR, LAC |
| PlaceboPlacebo in an OGTT (300 mL salt water, NaCl) =CTR with a stable isotope glucose tracer (D2-glucose) added to measure glucose. | Other | CTR, LAC |
Primary outcome
Difference in integrated glucose concentrations between CTR and LAC following an OGTT
Time frame: 0-240 minutes after the OGTT
7 secondary outcomes
Difference in glucose absorption
Time frame: 0-240 minutes after the OGTT
Difference in insulin sensitivity
Time frame: 0-240 minutes after the OGTT
Difference in insulin secretion
Time frame: 0-240 minutes
Difference in free fatty acids concentration
Time frame: 0-240 minutes after the OGTT
Difference in ventricular emptying rate
Time frame: 0-240 minutes after the OGTT
Difference in subjective appetite sensation
Time frame: 0-240 minutes after the intervention
Difference in integrated GLP-1 concentrations
Time frame: 0-240 minutes after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esben Søndergaard principal investigator
Aarhus University, Steno Diabetes Center Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactate in people with PreDiabetes and Metabolic Syndrome, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in integrated glucose concentrations between CTR and LAC following an OGTT (time frame: 0-240 minutes after the OGTT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.