A Phase 1 interventional study of Placebo (saline) and GIP in Effect of iv Administration of GIP and Alanine, sponsored by University Hospital, Gentofte, Copenhagen. Recruiting at 1 site in Denmark. Open to male participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-17.
Sponsored by University Hospital, Gentofte, Copenhagen · Phase 1, Interventional, and Basic science
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.
University Hospital, Gentofte, Copenhagen is the lead sponsor of 154 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intravenous administration of saline for 90 minutes.
Other: Placebo (saline)
Intravenous administration of GIP for 90 minutes (priming dose 6 pmol/kg/min for 10 minutes and 4 pmol/kg for 80 minutes.
Drug: GIP
Intravenous administration of alanine for 90 minutes (28 umol/kg/min).
Drug: Alanine
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.
Drug: GIP + alanine
Intravenous saline during experimental days.
Intravenous GIP administration during experimental days.
Intravenous alanine administration during experimental days.
Intravenous administration of GIP and alanine during experimental days.
Plasma concentrations of Glucagon
Baseline
Time frame: Timepoint -30 to 90 minutes
Plasma concentrations of Glucagon
Baseline-corrected area under the curve (bsAUC)
Time frame: Timepoint -30 to 90 minutes
Serum concentration of Insulin
Baseline
Time frame: Timepoint -30 to 90 minutes
Serum concentration of Insulin
Baseline-corrected area under the curve (bsAUC).
Time frame: Timepoint -30 to 90 minutes
Serum concentration of C-peptid
Baseline
Time frame: Timepoint -30 to 90 minutes
Serum concentration of C-peptid
Baseline-corrected area under the curve (bsAUC).
Time frame: Timepoint -30 to 90 minutes
Plasma concentration of glucose
Baseline
Time frame: Timepoint -30 to 90 minutes
Plasma concentration of glucose
Baseline-corrected area under the curve (bsAUC).
Time frame: Timepoint -30 to 90 minutes
Plasma concentration of glucose
Peak value
Time frame: Timepoint -30 to 90 minutes
Plasma concentration of GIP
Baseline
Time frame: Timepoint -30 to 90 minutes
Plasma concentration of GIP
Baseline-corrected area under the curve (bsAUC).
Time frame: Timepoint -30 to 90 minutes
Circulating levels of total amino acids
Baseline
Time frame: Timepoint -30 to 90 minutes
Circulating levels of total amino acids
Baseline-corrected area under the curve (bsAUC).
Time frame: Timepoint -30 to 90 minutes
Circulating levels of individual amino acids
Baseline
Time frame: Timepoint -30 to 90 minutes
Circulating levels of individual amino acids
Baseline-corrected area under the curve (bsAUC).
Time frame: Timepoint -30 to 90 minutes
Lipid profile
Baseline
Time frame: Timepoint -30 to 90 minutes
Lipid profile
Baseline-corrected area under the curve (bsAUC).
Time frame: Timepoint -30 to 90 minutes
Circulating levels of CTx
Baseline
Time frame: Timepoint -30 to 90 minutes
Circulating levels of CTx
Baseline-corrected area under the curve (bsAUC).
Time frame: Timepoint -30 to 90 minutes
Circulating levels of P1NP
Baseline
Time frame: Timepoint -30 to 90 minutes
Circulating levels of P1NP
Baseline-corrected area under the curve (bsAUC).
Time frame: Timepoint -30 to 90 minutes
Blood pressure
Baseline
Time frame: Timepoint -30, 0, 30, 60, 90
Blood pressure
Baseline-corrected area under the curve (bsAUC).
Time frame: Timepoint -30, 0, 30, 60, 90
Pulse
Baseline
Time frame: Timepoint -30, 0, 30, 60, 90
Pulse
Baseline-corrected area under the curve (bsAUC).
Time frame: Timepoint -30, 0, 30, 60, 90
Plan to share: No
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University Hospital, Gentofte, Copenhagen