Role of Adrenaline in in the Inflammatory Response in Diabetes

NCT ID: NCT05990933

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-03
• Study Completion Date: 2024-09-03

Brief Summary

The primary aim of the present study is to study the effect of adrenaline administration on inflammatory parameters (e.g. leukocyte phenotype, cytokines, inflammatory proteins). Secondary objectives consist of the effect of adrenaline on atherogenic parameters.

• All participants will receive intravenous infusion of adrenaline for an hour
• We will draw blood at 7 time points, not including screening
• Participants will be asked to return for a total of 4 times

Researchers will compare 2 groups, healthy individuals versus people with diabetes type 1 to see if the inflammatory reaction to adrenaline differs between these two groups.

Detailed Description

Objective: The aim of the present study is to study the effect of increased adrenaline levels on the inflammatory response (e.g. leukocyte phenotype, cytokines, inflammatory proteins) by administering exogenous adrenaline in participants with type 1 diabetes and healthy participants.

Potentially eligible adult ( 16 - 75 years) participants will be recruited from the diabetes clinic at the department of internal medicine from the Radboud University Medical Center. Healthy participants will be recruited through social media and other advertisements. We will recruit a total of 30 individuals, i.e. 15 healthy participants and 15 people with type 1 diabetes. Participants with type 1 diabetes will be equipped with a blinded continuous glucose monitoring device (CGM) during the test, which will measure interstitial glucose levels for a total of 10 days.

Intervention: All participants will receive intravenous infusion of adrenaline at a rate of 0.04ug/kg/min for 1 hour. We will draw blood at baseline, 30 minutes, 60 minutes, 180 minutes, 24 hours 72 hours and a week after start of infusion. The blood samples will be used for phenotyping of the innate immune system and measuring inflammatory and atherogenic parameters. Throughout the infusion, vital parameters will be monitored.

Conditions

Inflammatory Response; Diabetes Type1; Hypoglycemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

People with type 1 diabetes

The participants with type 1 diabetes will receive an intravenous infusion of adrenaline at a rate of 0.04ug/kg/min for 1 hour.

Group Type: EXPERIMENTAL

Adrenaline

Intervention Type: DRUG

Adrenaline infusion at a rate of 0.04ug/kg/min for 1 hour administered intravenously.

Healthy individuals

The participants without type 1 diabetes will receive an intravenous infusion of adrenaline at a rate of 0.04ug/kg/min for 1 hour.

Group Type: ACTIVE_COMPARATOR

Adrenaline

Intervention Type: DRUG

Adrenaline infusion at a rate of 0.04ug/kg/min for 1 hour administered intravenously.

Interventions

Adrenaline

Adrenaline infusion at a rate of 0.04ug/kg/min for 1 hour administered intravenously.

Intervention Type: DRUG

Other Intervention Names

Adrenaline infusion

Eligibility Criteria

Inclusion Criteria

• Ability to provide written informed consent
• Body-Mass Index: 19-30kg/m2
• Age ≥16 years, ≤ 75 years
• Blood pressure: <140/90 mmHg
• Non-smoking
• Electrocardiogram not showing any serious arrythmia's (PVC's and PAC's accepted)

Diabetes group specific criteria:

• Insulin treatment according to basal-bolus insulin regimen (injections or insulin pump)
• Duration of diabetes > 1 year
• HbA1c < 100 mmol/mol,

Exclusion Criteria

• Any event of cardiovascular disease in the past 5 years (e.g. myocardial infarction, stroke, heart failure, symptomatic peripheral arterial disease)
• Pregnancy or breastfeeding or unwillingness to undertake measures for birth control
• Epilepsy
• Current treatment with Alpha or beta blockers ( doxazosin, propranolol)
• History of panic disorders
• History of Arrhythmias
• Use of immune-modifying drugs or antibiotics
• Use of tricyclic antidepressants or MAO inhibitors
• Use of statins (e.g. stop statins >2 weeks before performing blood sampling.
• Any infection with systemic symptoms in past 2 weeks
• Previous vaccination in the past 2 weeks
• Proliferative retinopathy
• Nephropathy with an estimated glomerular filtration rate (by MDRD) ˂60ml/min/1.73m2

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cees Tack

OTHER

Sponsor Role: lead

Responsible Party

Cees Tack

Prof. Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Cees Tack, MD. PHD.

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center (Radboudumc)

Locations

Radboud UMC

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

114664

Identifier Type: -

Identifier Source: org_study_id