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| Name | Class |
|---|---|
| The Novo Nordisk Foundation Center for Basic Metabolic Research | OTHER |
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The objective of the study is to delineate the glucagonotropic signal exerted by selected amino acids in human subjects as well as the metabolic clearance rate of these amino acids after intravenous infusion
After being informed about the study and the potential risks, each participant giving written informed consent will participate in six experimental days. The glucagonotropic effect and metabolic clearance of selected amino acids and saline (placebo), respectively, will be evaluated in 12 healthy individuals. After screening, each participant will undergo 6 double-blinded experimental days performed in randomized order. The experimental days will each last 75 minutes. The amino acids selected for the experiment are glutamine, arginine, alanine, leucine and proline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary arm | Experimental | This is a single-arm study. Each subject will participate in 6 experimental days in a randomized order. The interventions are equimolar bolus infusions of A) glutamine, B) arginine, C) alanine, D) leucine, E) proline and F) saline (placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amino acid bolus infusion | Other | Equimolar bolus infusions of amino acids or saline (placebo) |
|
| Measure | Description | Time Frame |
|---|---|---|
| bsAUC30 | Baseline subtracted area under the curve for glucagon concentration during the first 30 minutes of the experiment | bsAUC is calculated from blood samples drawn at times 0 min, 1 min, 2 min, 4 min, 6 min, 10 min, 15 min and 30 min |
| Measure | Description | Time Frame |
|---|---|---|
| AUC30 | total area under the curve for glucagon concentration during the first 30 minutes of the experiment | AUC30 is calculated from blood samples drawn at times 0 min, 1 min, 2 min, 4 min, 6 min, 10 min, 15 min and 30 min |
| AUC60 |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic clearance of amino acids | The metabolic clearance of each infused amino acid calculated from amino acid concentrations | Time 0 min to time 60 min |
| Insulin | plasma concentration of insulin during the experiment |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Metabolic Research | Hellerup | 2900 | Denmark |
All published data will be made available to other researchers upon reasonable request
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randomized, double-blinded, single-arm study. Participants act as their own controls.
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total area under the curve for glucagon concentration the first 60 minutes of the experiment
| AUC60 is calculated from blood samples drawn at times 0 min, 1 min, 2 min, 4 min, 6 min, 10 min, 15 min, 30 min and 60 min |
| bsAUC60 | Baseline subtracted area under the curve for glucagon concentration during the first 60 minutes of the experiment | bsAUC60 is calculated from blood samples drawn at times 0 min, 1 min, 2 min, 4 min, 6 min, 10 min, 15 min, 30 min and 60 min |
| peak glucagon concentration | the highest concentration of glucagon after infusion of amino acids/placebo | measured between time 0 min and time 60 min |
| Time -15 min to time 60 min |
| C-peptide | plasma concentration of C-peptide during the experiment | Time -15 min to time 60 min |
| Total and individual amino acids | plasma concentration of total and individual amino acids during the experiment | Time -15 min to time 60 min |
| GLP-1 | plasma concentration of glucagon-like peptide 1 (GLP-1) during the experiment | Time -15 min to time 60 min |
| GIP | plasma concentration of glucose-dependent insulinotropic polypeptide (GIP) during the experiment | Time -15 min to time 60 min |