Inflammatory ResponseRAIDNCT05990933
Role of Adrenaline in in the Inflammatory Response in Diabetes
A study testing Adrenaline in people with Inflammatory Response and Diabetes Type1, run by Cees Tack at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Response, Diabetes Type1, Hypoglycemia
- What is being tested?
- Adrenaline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Dec 2023to 3 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Adrenaline in the Inflammatory Response in People with Diabetes Mellitus Type 1, and Healthy Individuals
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.
Read the 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
- Being tested
- Adrenaline
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdrenalineDrug
Also called Adrenaline infusion
Adrenaline infusion at a rate of 0.04ug/kg/min for 1 hour administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Adrenaline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocyte count
The amount of monocytes following 60 minutes of adrenaline infusion compared to baseline to asses the adrenaline effect on the inflammatory response.
Measured: Change from baseline compared to after 1 hour
Secondary outcomes (11)
Leukocyte count
Measurement of the amount of leukocytes
Measured: Change from baseline at day 30, 60 and 180 minutes 1, day 3 and day 7 after adrenaline infusion
Leukocyte phenotype
Measuring several phenotypes by using a pre-defined panel of interest with flow-cytometry ( e.g. NK-cells, granulocytes)
Measured: Change from baseline at day 30, 60 and 180 minutes 1, day 3 and day 7 after adrenaline infusion
Pro-inflammatory proteins
Pro-inflammatory proteins using Olink Proteomics AB inflammation panel with 92 circulating inflammatory proteins ( e.g. EN-rage, FIT3L)
Measured: Change from baseline at day 30, 60 and 180 minutes 1, day 3 and day 7 after adrenaline infusion
Inflammation plasma parameters
Inflammatory plasma protein using ELISA, ( e.g high sensitive-crp)
Measured: Change from baseline at 30, 60 and 180 minutes day 1, day 3 and day 7 after adrenaline infusion
Atherogenic parameters
Atherogenic parameters using ELISA method including but not limited to, VCAM-1, ICAM-1, E-Selectin, P-selectin, PAI-1, Plasma Endothelin
Measured: Change from baseline at 30, 60 and 180 minutes day 1, day 3 and day 7 after adrenaline infusion
Insulin
Plasma levels of insulin
Measured: Change from baseline at, 60 and 180 minutes
Adrenaline
Plasma levels of adrenaline
Measured: Change from baseline at 30, 60 and 180 minutes
Noradrenaline
Plasma levels of noradrenaline
Measured: Change from baseline at 30, 60 and 180 minutes
Glucose variability
Glucose variability measured by the blinded continuous glucose monitor including but not limited to, measuring time within range, amount of hypoglycaemic events, amount of hyperglycaemic events.
Measured: 2 weeks
Ex vivo cytokines
Ex vivo production of pro- and anti-inflammatory cytokines and chemokines after ex vivo stimulation of isolated monocytes, including TNF-α, IL-6, IL-10 and IL-1β.
Measured: Change from baseline at 30, 60 and 180 minutes, day 1, day 3 and day 7 after adrenaline infusion
Distribution of monocyte subset
Distribution of pro- and anti-inflammatory monocyte subsets using FACS (Fluorescence-activated Cell Sorting)
Measured: Change from baseline at 30, 60 and 180 minutes, day 1, day 3 and day 7 after adrenaline infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start3 Dec 2023
- Primary completion3 Sep 2024
- Study completion3 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cees Tack
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cees Tack, Radboud University Medical Center
- Investigators
- Cees Tack, MD. PHD., Principal investigator, Radboud University Medical Center (Radboudumc)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990933
- Sponsor's protocol ID
- 114664
- Acronym
- RAID
- Status last verified
- Sep 2024
- First submitted
- 2 Aug 2023
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: WE will share the study protocol using a data respository accesible through the research team on demand. Starting around 6 months after publication.
Publications
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 Jun;69(6):1675-1685. doi: 10.1007/s00125-026-06667-9. Epub 2026 Jan 29.
PubMed 41611977
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Adrenaline in the Inflammatory Response in People with Diabetes Mellitus Type 1, and Healthy Individuals
- ClinicalTrials.gov ID
- NCT05990933
- Acronym / sponsor ID
- RAID / 114664
- Conditions
- Inflammatory Response, Diabetes Type1, Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cees TackUniversity, hospital or other
- Study start
- 3 Dec 2023 (actual)
- Primary completion
- 3 Sep 2024 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| People with type 1 diabetes | Experimental | Drug: AdrenalineThe participants with type 1 diabetes will receive an intravenous infusion of adrenaline at a rate of 0.04ug/kg/min for 1 hour. |
| Healthy individuals | Active comparator | Drug: AdrenalineThe participants without type 1 diabetes will receive an intravenous infusion of adrenaline at a rate of 0.04ug/kg/min for 1 hour. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdrenalineAlso: Adrenaline infusionAdrenaline infusion at a rate of 0.04ug/kg/min for 1 hour administered intravenously. | Drug | Healthy individuals, People with type 1 diabetes |
Primary outcome
Monocyte count
Time frame: Change from baseline compared to after 1 hour
The amount of monocytes following 60 minutes of adrenaline infusion compared to baseline to asses the adrenaline effect on the inflammatory response.
11 secondary outcomes
Leukocyte count
Time frame: Change from baseline at day 30, 60 and 180 minutes 1, day 3 and day 7 after adrenaline infusion
Leukocyte phenotype
Time frame: Change from baseline at day 30, 60 and 180 minutes 1, day 3 and day 7 after adrenaline infusion
Pro-inflammatory proteins
Time frame: Change from baseline at day 30, 60 and 180 minutes 1, day 3 and day 7 after adrenaline infusion
Inflammation plasma parameters
Time frame: Change from baseline at 30, 60 and 180 minutes day 1, day 3 and day 7 after adrenaline infusion
Atherogenic parameters
Time frame: Change from baseline at 30, 60 and 180 minutes day 1, day 3 and day 7 after adrenaline infusion
Insulin
Time frame: Change from baseline at, 60 and 180 minutes
Adrenaline
Time frame: Change from baseline at 30, 60 and 180 minutes
Noradrenaline
Time frame: Change from baseline at 30, 60 and 180 minutes
Glucose variability
Time frame: 2 weeks
Ex vivo cytokines
Time frame: Change from baseline at 30, 60 and 180 minutes, day 1, day 3 and day 7 after adrenaline infusion
Distribution of monocyte subset
Time frame: Change from baseline at 30, 60 and 180 minutes, day 1, day 3 and day 7 after adrenaline infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Derived from this study: PubMed 41611977Mustafajev IF, Hendriksz MS, Stienstra R, Tack CJ, de Galan BE, Meijer RI. Adrenaline is a prominent driver of inflammatory responses following hypoglycaemia. Diabetologia. 2026 Jun;69(6):1675-1685. doi: 10.1007/s00125-026-06667-9. Epub 2026 Jan 29.
- Individual participant dataSharing planned: Yes. WE will share the study protocol using a data respository accesible through the research team on demand. Starting around 6 months after publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cees Tack, MD. PHD. principal investigator
Radboud University Medical Center (Radboudumc)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adrenaline in people with Inflammatory Response and Diabetes Type1, run by Cees Tack at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monocyte count (time frame: Change from baseline compared to after 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05990933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.