Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06265337
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2024-02-05
Brief Title:
Does Co-administration of Lactate to an Oral Glucose Tolerance Test Lower the Glucose Response
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Does Co-administration of Lactate to an Oral Glucose Tolerance Test Lower the Glucose Response
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To investigate whether co-administration of lactate with a glucose load affects postprandial glucose levelshandling gastrointestinal hormones gastric emptying and appetite sensations in individuals with pre-diabetes when compared to placebo
Hypothesis
Oral lactate administration improveslowers glucose excursions following an oral glucose tolerance test OGTT by stimulating insulin secretion and delaying glucose absorption
Hypothesis
Oral lactate administration improveslowers 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
1 Placebo in an OGTT 300 mL salt water NaCl CTR or
2 Lactate in an OGTT 300 mL lactate drink 25 g DL-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 012 mCimin 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 α005 β080 This is similar to the effect size observed in studies investigating the treatment with a dipeptidyl peptidase-4 inhibitor a weak insulin secretagogue
Trial days
The two trial days will be completely alike besides the interventions consisting of either
1 Placebo in an OGTT 300 mL salt water NaCl CTR or
2 Lactate in an OGTT 300 mL lactate drink 25 g DL-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 012 mCimin 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 α005 β080 This is similar to the effect size observed in studies investigating the treatment with a dipeptidyl peptidase-4 inhibitor a weak insulin secretagogue
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None