Glucagon-induced changes in heart rate, blood pressure, cardiac output. and metabolic effects
Conditions
Interventions
Trade Name: Glucagen Hypokit
Product Name: Glucagen Hypokit
Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion
Pharmaceutical form of the placebo: Infusion
Route of
Sponsors
Bispebjerg Hospital, University of Copenhagen
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Eligible participants are males 18 to 40 years of age determined to be healthy by physical examination, medical history and routine laboratory tests (blood and urine) - i.e. normal levels of sodium, potassium, calcium, liver function, kidney function, hematological parameters, albumin, HbA1c, lipid levels. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Routine laboratory tests outside normal ranges • Hypertension • Second and third degree atrioventricular conduction block • Resting Systolic blood pressure >140 or <100 mmHg • Resting heart rate < 45 beats per minute (bpm) • Sick sinus syndrome • Pheochromocytoma • Asthma • Chronic obstructive pulmonary disease • Abnormal body mass index • Claudicatio intermittens • Raynaud syndrome • Latex allergy • Any contraindications to glucagon Any other previous or existing metabolic, heart or lung disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To observe the clinical effects of glucagon - compared to placebo - on hemodynamic parameters (blood pressure, heart rate and cardiac output) in healthy volunteers. ;Secondary Objective: To observe the clinical effects of glucagon - compared to placebo on metabolic effects (on insulin, glucose, and amino acid levels) and register any potential adverse effects of glucagon;Primary end point(s): Change in heart rate compared between study days ;Timepoint(s) of evaluation of this end point: baseline and glucagon +5, +10, +15, +20, +30, +40, +50, +60, 90 minutter | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): changes is blood pressure, cardiac inotropy and metabolic effects;Timepoint(s) of evaluation of this end point: baseline and glucagon +5, +10, +15, +20, +30, +40, +50, +60, 90 minutter | — |
Countries
Denmark
Contacts
Public ContactBispebjerg Hospital, University of
Bispebjerg Hospital, University of Copenhagen
Outcome results
None listed