Cardiovascular effects of Insuli

Phase 1

• Conditions: Insulin-induced increased heart rate, blood pressure and cardiacoutput; MedDRA version: 20.1Level: LLTClassification code 10035785Term: Poisoning by agents primarily affecting the cardiovascular systemSystem Organ Class: 100000004863; Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

• Registration Number: EUCTR2017-002553-11-DK
• Lead Sponsor: Bispebjerg Hospital, University of Copenhagen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-06
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 10

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

•Previous or existing
metabolic disease
Routine laboratory tests outside normal ranges
• Any heart disease
• Hypertension
• Second and third degree atrioventricular conduction block
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• 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
• Diabetes
• Latex allergy
• Any contraindications to beta-blockers

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To observe the clinical effects of insulin, compared to placebo, on<br>hemodynamic parameters (blood pressure, heart rate and cardiac<br>output) in states of normal and beta-blocker-induced heart rate and<br>blood pressure suppression in healthy volunteers;Secondary Objective: To observe the effects of Insulin on clinical and biochemical measures<br>of resting energy expenditure and metabolism (ie free fatty acids) on days with insulin compared to days with placebo.<br>Furthermore, adverse reactions associated with insulin/placebo<br>administration are recorded.<br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): 1: Change in blood pressure (systolic, diastolic and mean arterial<br>pressure in mmHg) and heart rate from baseline<br>compared between study days<br>2: Effects of Insulin on stroke volume, heart rate and blood pressure<br>parameters compared to days with placebo.<br>3: Percent change in plasma levels biochemical measurements<br>(cholesterol, low density lipoprotein, high-density lipoprotein, glucose,<br>sodium, potassium)<br>4: Peak plasma concentration (Cmax), time to peak plasma<br>concentration (Tmax) and area under the plasma concentration versus<br>time curve (AUC) of paracetamol on days with co-administration of<br>insulin compared to days with placebo (saline).<br> ;Timepoint(s) of evaluation of this end point: 1: From baseline (T=0) to T+240 minutes.<br>2: T-15, T 0, T 5, T 15, T 30, T 45, T 60, T 90, T 120, T180, T240<br>3: Baseline, +30, +60, +90,+120, +240 minutes.<br>4: Baseline (T=0), +15, +30, +45, +60, +120, +240, +255,+270,+300 minutes.<br>