Insulin-induced increased heart rate, blood pressure and cardiac output MedDRA version: 20.1 Level: LLT Classification code 10035785 Term: Poisoning by agents primarily affecting the cardiovascular system System Organ Class: 100000004863
Conditions
Interventions
Trade Name: Actrapid
Product Name: Actrapid
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: INSULIN HUMAN
CAS Number: 11061-68-0
Concentration unit: IU/ml international
Sponsors
Bispebjerg Hospital, University of Copenhagen
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Eligible participants are males 18 to 39 years of age determined to be healthy by physical examination, medical history and routine laboratory tests (blood and urine) (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 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Previous or existing metabolic disease Routine laboratory tests outside normal ranges • Any heart disease • Hypertension • Second and third degree atrioventricular conduction block XML File Identifier: sfGLcI6N1h13DS3BCrgS2oy47jU= Page 10/19 • Resting Systolic blood pressure >140 or 45 beats per minute (bpm) • Sick sinus syndrome • Pheochromocytoma • Asthma • Chronic obstructive pulmonary disease • Abnormal body mass index • Claudicatio intermittens • Raynaud syndrome • Diabetes • Latex allergy • Any contraindications to beta-blockers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To observe the clinical effects of insulin, compared to placebo, on hemodynamic parameters (blood pressure, heart rate and cardiac output) in states of normal and beta-blocker-induced heart rate and blood pressure suppression in healthy volunteers;Secondary Objective: To observe the effects of Insulin on clinical and biochemical measures of resting energy expenditure and metabolism (ie free fatty acids) on days with insulin compared to days with placebo. Furthermore, adverse reactions associated with insulin/placebo administration are recorded. Gastric emptying time on days with insulin compared to placebo;Primary end point(s): Change in cardiac output from baseline compared between study days;Timepoint(s) of evaluation of this end point: From baseline (T=0) to T+240 minutes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1: Change in blood pressure (systolic, diastolic and mean arterial pressure in mmHg) and heart rate from baseline compared between study days 2: Effects of Insulin on stroke volume, heart rate and blood pressure parameters compared to days with placebo. 3: Percent change in plasma levels biochemical measurements (cholesterol, low density lipoprotein, high-density lipoprotein, glucose, sodium, potassium) 4: Peak plasma concentration (Cmax), time to peak plasma concentration (Tmax) and area under the plasma concentration versus time curve (AUC) of paracetamol on days with co-administration of insulin compared to days with placebo (saline). ;Timepoint(s) of evaluation of this end point: 1: From baseline (T=0) to T+240 minutes. 2: T-15, T 0, T 5, T 15, T 30, T 45, T 60, T 90, T 120, T180, T240 3: Baseline, +30, +60, +90,+120, +240 minutes. 4: Baseline (T=0), +15, +30, +45, +60, +120, +240, +255,+270,+300 minutes. | — |
Countries
Denmark
Contacts
Public ContactDepartment of Clinical Pharmacology
Bispebjerg hospital, University of Copenhagen
Outcome results
None listed