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The study is a randomised, double-blinded, placebo-controlled, crossover study enrolling 10 healthy male participants. Each participant will undergo four separate study days in randomised order. Each study day encompasses a continous 90-minute i.v. infusion with either placebo, glucose-dependent insulinotropic polypeptide (GIP), alanine or GIP + alanine.
The primary objective of the study is to find out whether intravenous administration of the naturally occuring gut hormone GIP and the amino acid alanine, separately and combined, results in additive or synergistic glucagonotropic effects during euglycaemic conditions in healthy participants. Secondary objectives are to disclose the effect of the abovementioned interventions on insulin secretion and circulating levels of total and individual amino acids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline | Placebo Comparator | Intravenous administration of saline for 90 minutes. |
|
| GIP | Experimental | Intravenous administration of GIP for 90 minutes (priming dose 6 pmol/kg/min for 10 minutes and 4 pmol/kg for 80 minutes. |
|
| Alanine | Experimental | Intravenous administration of alanine for 90 minutes (28 umol/kg/min). |
|
| GIP + Alanine | Experimental | Intravenous administration of GIP and alanine for 90 minutes. GIP is given at a priming dose of 6 pmol/kg/min for 10 minutes and then 4 pmol/kg for 80 minutes. Alanine is given at 28 umol/kg/min for 90 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo (saline) | Other | Intravenous saline during experimental days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of Glucagon | Baseline | Timepoint -30 to 90 minutes |
| Plasma concentrations of Glucagon | Baseline-corrected area under the curve (bsAUC) | Timepoint -30 to 90 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentration of Insulin | Baseline | Timepoint -30 to 90 minutes |
| Serum concentration of Insulin | Baseline-corrected area under the curve (bsAUC). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie V Warnøe, MD | Contact | +4527282263 | julie.vilhelmine.warnoee.nielsen@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Filip K Knop, MD, PhD | Center for Clinical Metabolic Research, Gentofte Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Metabolic Research, Gentofte Hospital | Recruiting | Hellerup | Capital Region | 2900 | Denmark |
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| GIP |
| Drug |
Intravenous GIP administration during experimental days. |
|
| Alanine | Drug | Intravenous alanine administration during experimental days. |
|
| GIP + alanine | Drug | Intravenous administration of GIP and alanine during experimental days. |
|
| Timepoint -30 to 90 minutes |
| Serum concentration of C-peptid | Baseline | Timepoint -30 to 90 minutes |
| Serum concentration of C-peptid | Baseline-corrected area under the curve (bsAUC). | Timepoint -30 to 90 minutes |
| Plasma concentration of glucose | Baseline | Timepoint -30 to 90 minutes |
| Plasma concentration of glucose | Baseline-corrected area under the curve (bsAUC). | Timepoint -30 to 90 minutes |
| Plasma concentration of glucose | Peak value | Timepoint -30 to 90 minutes |
| Plasma concentration of GIP | Baseline | Timepoint -30 to 90 minutes |
| Plasma concentration of GIP | Baseline-corrected area under the curve (bsAUC). | Timepoint -30 to 90 minutes |
| Circulating levels of total amino acids | Baseline | Timepoint -30 to 90 minutes |
| Circulating levels of total amino acids | Baseline-corrected area under the curve (bsAUC). | Timepoint -30 to 90 minutes |
| Circulating levels of individual amino acids | Baseline | Timepoint -30 to 90 minutes |
| Circulating levels of individual amino acids | Baseline-corrected area under the curve (bsAUC). | Timepoint -30 to 90 minutes |
| Lipid profile | Baseline | Timepoint -30 to 90 minutes |
| Lipid profile | Baseline-corrected area under the curve (bsAUC). | Timepoint -30 to 90 minutes |
| Circulating levels of CTx | Baseline | Timepoint -30 to 90 minutes |
| Circulating levels of CTx | Baseline-corrected area under the curve (bsAUC). | Timepoint -30 to 90 minutes |
| Circulating levels of P1NP | Baseline | Timepoint -30 to 90 minutes |
| Circulating levels of P1NP | Baseline-corrected area under the curve (bsAUC). | Timepoint -30 to 90 minutes |
| Blood pressure | Baseline | Timepoint -30, 0, 30, 60, 90 |
| Blood pressure | Baseline-corrected area under the curve (bsAUC). | Timepoint -30, 0, 30, 60, 90 |
| Pulse | Baseline | Timepoint -30, 0, 30, 60, 90 |
| Pulse | Baseline-corrected area under the curve (bsAUC). | Timepoint -30, 0, 30, 60, 90 |
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D000409 | Alanine |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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