- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04299815
Lactate in the Gut
Lactate is formed naturally in the body in example during physical activity. However, lactate is also formed during food fermentation where certain bacterial strains form lactate. Lactate can also be produced chemically. An example of this is Ringer-lactate which is used for volume replacement when treating dehydrated patients.
As a source of carbon-molecules, lactate is believed to be an important oxidative fuel source in all major organs and yields adenosine triphosphate (ATP) production through Krebs cycle, the Electron Transport Chain in the mitochondria as well as by being a key precursor for gluconeogenesis.
Metformin is the first drug of choice for type 2 diabetes treatment. Use of metformin often results in a small but significant weight loss in overweight users. It is known that metformin increases the lactate concentration in the gut. It is also known also know that metformin use is associated with an increase in blood concentrations of growth differentiation factor 15 (GDF-15). Receptors for GDF-15 can be found in parts of the brain associated with control of appetite. In rats increases in [GDF-15] results in a decrease in appetite and thus weight loss. GDF-15 is thought to be involved in the normal energy homeostasis.
With this study the investigators want to examine the hormonal, metabolic and mechanical effects of lactate in the gut in healthy volunteers. Our hypothesis is that lactate has beneficial effects which may be though an increase in GDF-15 in the blood.
Volunteers will undergo two study days separated by at least 7 days and a maximum of 1 month.
- On day one volunteers will drink a sodium-lactate solution (intervention). The investigators will also administrate 1500mg paracetamol to assess gastric emptying and do blood samples over 4 hours. The investigators measure [lactate] every 15 min. Every hour the investigators will ask volunteers questions regarding hunger and thoughts of future food intake (questionnaire). After 4 hours of blood sampling the investigators will serve volunteers an all-you-can-eat meal of sandwich and measure how must they ate.
- On day two volunteers will drink a sodium chloride solution. Furthermore, the investigators administrate intravenous D/L sodium lactate in order to reach the same plasma [lactate] on day 2 as was done on day 1. The rest of day two is identical to day 1.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Aarhus, Denmark, 8200
- Aarhus University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male gender
- Age 18-50 years
- BMI 20-30 kg/m2
- In good health with no daily use of prescription medicine based on medical history, clinical examination and blood samples.
- Spoken and written informed consent
Exclusion Criteria:
- Chronic illness or daily use of prescription medicine .
- Abnormal screening blood samples as judged by the PI
- Does not understand or speak Danish
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Oral lactate
Sodium D/L lactate solution, 25g/L in 300mL water
|
25 grams of D/L lactate dissolved in 300mL water.
|
Placebo Comparator: Iso-lactic intravenous lactate infusion
iv sodium D/L lactate to elevate [lactate] to the same levels as measured on day 1 + oral sodium chloride, 300 mL
|
intravenous sodium lactate + oral sodium-chlorid solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GDF-15
Time Frame: 4 hours
|
Difference in [GDF-15] between intervention and placebo
|
4 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
glucagon-like peptide -1
Time Frame: 4 hours
|
Difference in [glucagon-like peptide -1] between intervention and placebo
|
4 hours
|
Gastric inhibitory peptide (GIP)
Time Frame: 4 hours
|
Difference in plasma [GIP] between intervention and placebo
|
4 hours
|
free fatty acid
Time Frame: 4 hours
|
Difference in [free fatty acid ] between intervention and placebo
|
4 hours
|
cholecystokinin
Time Frame: 4 hours
|
Difference in [cholecystokinin] between intervention and placebo
|
4 hours
|
Ghrelin
Time Frame: 4 hours
|
Difference in [Ghrelin] between intervention and placebo
|
4 hours
|
Gastrin
Time Frame: 4 hours
|
Difference in [Gastrin] between intervention and placebo
|
4 hours
|
C-peptide
Time Frame: 4 hours
|
Difference in [C-peptide] between intervention and placebo
|
4 hours
|
glucose
Time Frame: 4 hours
|
Difference in [glucose] between intervention and placebo
|
4 hours
|
gastric emptying
Time Frame: 4 hours
|
[Paracetamol] to asses gastric emptying
|
4 hours
|
Evaluation of hunger
Time Frame: 4 hours
|
Evaluation of hunger, thoughts of future food intake ect using a questionnaire
|
4 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Nikolaj Rittig, postdoc, Steno Diabetes Center Aarhus (SDCA), Aarhus universitetshospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-10-72-8-20
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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