Role of Adrenaline in in the Inflammatory Response in Diabetes

NCT05990933 | Completed

• 1 other identifier: 114664
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Response; Diabetes Type1; Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Monocyte count

  The amount of monocytes following 60 minutes of adrenaline infusion compared to baseline to asses the adrenaline effect on the inflammatory response.

  Change from baseline compared to after 1 hour

Secondary Outcomes (11)

• Leukocyte count

  Change from baseline at day 30, 60 and 180 minutes 1, day 3 and day 7 after adrenaline infusion

• Leukocyte phenotype

  Change from baseline at day 30, 60 and 180 minutes 1, day 3 and day 7 after adrenaline infusion

• Pro-inflammatory proteins

  Change from baseline at day 30, 60 and 180 minutes 1, day 3 and day 7 after adrenaline infusion

• Inflammation plasma parameters

  Change from baseline at 30, 60 and 180 minutes day 1, day 3 and day 7 after adrenaline infusion

• Atherogenic parameters

  Change from baseline at 30, 60 and 180 minutes day 1, day 3 and day 7 after adrenaline infusion

Study Arms (2)

People with type 1 diabetes

EXPERIMENTAL

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

Drug: Adrenaline

Healthy individuals

ACTIVE COMPARATOR

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

Drug: Adrenaline

Interventions

Adrenaline DRUG

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

Also known as: Adrenaline infusion

Healthy individuals; People with type 1 diabetes

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Cees Tack: lead

Study Sites (1)

Radboud UMC

Nijmegen, Gelderland, 6525GA, Netherlands

Location

Related Publications (1)

• Mustafajev IF, Hendriksz MS, Stienstra R, Tack CJ, de Galan BE, Meijer RI. Adrenaline is a prominent driver of inflammatory responses following hypoglycaemia. Diabetologia. 2026 Jan 29. doi: 10.1007/s00125-026-06667-9. Online ahead of print.

  PMID: 41611977 DERIVED

MeSH Terms

Conditions

Hypoglycemia

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Cees Tack, MD. PHD.

  Radboud University Medical Center (Radboudumc)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: 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 and a week after start of infusion. These 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.

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 14, 2023
• Study Start: December 3, 2023
• Primary Completion: September 3, 2024
• Study Completion: September 3, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months after publication
• Access Criteria: The coordinating researcher will review acces requests. Seeing as the data are all anonimised acces will be granted for additional research in the field of inflammation or diabetes.

Locations

NL (1)