Diabetes Mellitus, Type 1RAID-IINCT06422494
The Role of the Adrenergic System in Hypoglycaemia Induced Inflammatory Response in People With Type 1 Diabetes and People Without Type 1 Diabetes-RAID-II
A study testing hyperinsulinaemic hypoglycaemic clamp, Propranolol Hydrochloride 1 MG/ML and Phentolamine in people with Diabetes Mellitus, Type 1 and Inflammation, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The goal of this trial is to study the effect that adrenaline has on the immune reaction seen during a low blood sugar. People with type 1 diabetes do not produce their own insulin. The cells in the pancreas that produce insulin are destroyed. People with type 1 diabetes require daily insulin administration. Read more about this study
- Who is it for?
- Ages 16 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1, Inflammation
- What is being tested?
- hyperinsulinaemic hypoglycaemic clamp, Propranolol Hydrochloride 1 MG/ML and Phentolamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Sep 2025to 28 Sep 2025
- 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
- Overall inclusion criteria:
- Ability to provide written informed consent
- Body-Mass Index: 18,5-35 kg/m2
- Age ≥16 years, ≤ 75 years
- Blood pressure: <140/90 mmHg
- Non-smoking
Show all 11Show fewer
- Electrocardiogram not showing any serious arrythmias (premature ventricular complexes and premature atrial complexes 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,
Who cannot join
- Any event of cardiovascular disease in the past 5 years (e.g. myocardial infarction, stroke, symptomatic peripheral arterial disease)
- Pregnancy or breastfeeding or unwillingness to undertake measures for birth control
- Active epilepsy ( with the need for treatment)
- Allergy for sulphite
- Active asthma with use of β2-bronchodilators or obstructive lung disease
- Current treatment with Alpha- or beta-blockers (e.g. doxazosin, propranolol)
Show all 13Show fewer
- History of clinical significant Arrhythmias
- Use of immune-modifying drugs or antibiotics
- Use of antidepressants ( Including monoamine oxidase inhibitors, tricyclic antidepressants and serotonin-reuptake inhibitors)
- Use of antipsychotics
- Use of statins with the inability to stop statins >2 weeks before the investigational day.
- Proliferative retinopathy
- Nephropathy with an estimated glomerular filtration rate (by Chronic Kidney Disease Epidemiology Collaboration equation, CKD-EPI) ˂60ml/min/1.73m2
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Medical Center, Nijmegen, Netherlands
Nijmegen, Gelderland, 6525 GA
About this study
The goal of this trial is to study the effect that adrenaline has on the immune reaction seen during a low blood sugar. People with type 1 diabetes do not produce their own insulin. The cells in the pancreas that produce insulin are destroyed. People with type 1 diabetes require daily insulin administration. As a consequence of this insulin therapy the blood sugar can dip too low, causing symptoms such as confusion, irritation and tiredness. This is called hypoglycaemia. Hypoglycaemia has been associated with an increased risk for cardiovascular disease such as heart attacks. During hypoglycaemia the immune system is activated. The immune system consists of white blood cells which produce cytokines, these are proteins used to kill pathogens such as bacteria. During hypoglycaemia there are no pathogens but the cytokines are still produced, leading to unwanted damage. A previous study performed by our research group showed that the immune system activation caused by hypoglycaemia is associated with the stress hormone adrenaline. Adrenaline is released by the body in moments of stress such as during running or bungee jumping. Adrenaline is also released by the body during hypoglycaemia to increase the sugar level. Our hypothesis is that adrenaline activates the immune system during hypoglycaemia. Adrenaline acts in the body through two receivers, these are called alpha and beta receptors. These are present on almost all cells in the body especially on the immune cells. With the study we want to study the situation where there is a hypoglycaemia without the adrenaline. We will achieve this by lowering the blood sugar in participants. During the low blood sugar we will administer two drugs, which will attach themselves to the adrenaline receivers, the alpha and beta receptor. With this method we hope to block the adrenaline effects and with that block the immune response caused by adrenaline.
Read the detailed description
Rationale: Hypoglycaemia has shown to cause a sustained pro-inflammatory response which could promote a pro-atherogenic state and explain the association between hypoglycaemia and cardiovascular events. This pro-inflammatory response has been linked to the adrenaline response to hypoglycaemia. Adrenergic blockade with α and β adrenergic receptor antagonists (ARA) has shown to blunt the leukocyte response after hypoglycaemia induction and adrenaline administration. Whether and to what degree a combined blockade blunts the hypoglycaemia induced pro-inflammatory response is unknown.
Objective: to examine the effect of adrenergic inhibition on the hypoglycaemia induced inflammatory response (e.g. leukocyte phenotype, cytokines, inflammatory proteins) by performing a hyperinsulinaemic hypoglycaemic glucose clamp alongside infusion of α-ARA and β-ARA. Secondary objectives consist of the effect of adrenergic blockade during hypoglycaemia on atherogenic parameters and glucose metrics ( e.g. time in range).
Study design: Intervention study with a cross-over design
Study population: Potentially eligible adult ( 16 - 75 years) participants will be recruited through social media, the Radboudumc outpatient clinic and other advertisements. We will recruit a total of 24 individuals, i.e. 12 healthy participants and 12 participants with type 1 diabetes. Participants with type 1 diabetes will be twice ( as there are two investigational days) 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 undergo a hyperinsulinaemic hypoglycaemic glucose clamp ( nadir 2.8 mmol/L). During the clamp the participants will be randomized to receive an infusion of saline or an infusion of phentolamine and propranolol. This will be done using a cross-over design. The participants will undergo both the saline and adrenergic blockade.
Main study parameters/endpoints: The main study parameter will be the monocyte count after 60 minutes hyperinsulinaemic hypoglycaemic clamp and adrenergic blockade during the clamp.
- Conditions
- Diabetes Mellitus, Type 1, Inflammation
- Being tested
- hyperinsulinaemic hypoglycaemic clamp, Propranolol Hydrochloride 1 MG/ML, Phentolamine
- Medical subject headings
- Diabetes Mellitus, Type 1, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperinsulinaemic hypoglycaemic clampDrug
Insulin will be infused at a continuous rate of 60 mU∙m-2 ∙min-1 and glucose 20% will be infused at a variable rate, aiming for stable plasma glucose levels of 5.0 mmol/L. The infusion rate of glucose will be adjusted by plasma glucose levels, measured at 5-minute intervals. After 30 minutes of stable euglycaemia, plasma glucose levels will be allowed to drop gradually to 2.8 mmol/L and will be maintained at this level for 60 minutes. Then, insulin infusion and adrenergic blockade infusions will be stopped. Glucose infusion will be increased and then tapered until stable euglycaemia plasma levels are reached.
Propranolol Hydrochloride 1 MG/MLDrug
When euglycaemic level of 5.0mmol/L is achieved we will start the adrenergic blockade which will continue throughout euglycaemia and hypoglycaemia. The participants will be administered a bolus of phentolamine of 70µg/kg followed by a dose of 7.0µg/kg/min continuous infusion and a bolus of propranolol of 14µg/kg followed by a dose of 1.4µg/kg/min.
PhentolamineDrug
When euglycaemic level of 5.0mmol/L is achieved we will start the adrenergic blockade which will continue throughout euglycaemia and hypoglycaemia. The participants will be administered a bolus of phentolamine of 70µg/kg followed by a dose of 7.0µg/kg/min continuous infusion and a bolus of propranolol of 14µg/kg followed by a dose of 1.4µg/kg/min.
| Study group | Role | What they receive |
|---|---|---|
| Participants without type 1 diabetes | Active comparator | The participants without type 1 diabetes Receives: Drug: hyperinsulinaemic hypoglycaemic clamp; Drug: Propranolol Hydrochloride 1 MG/ML; Drug: Phentolamine |
| Participants with type 1 diabetes | Active comparator | Participants with type 1 diabetes Receives: Drug: hyperinsulinaemic hypoglycaemic clamp; Drug: Propranolol Hydrochloride 1 MG/ML; Drug: Phentolamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocyte count after 60 minutes of hypoglycaemia and adrenergic blockade
The number of monocytes following 60 minutes hypoglycaemia and adrenergic blockade compared to baseline. Adrenergic blockade using Phentolamine and Propranolol intravenously. Expressed in 10^3/µl measured using a sysmex machine.
Measured: After 60 minutes of hypoglycaemia and adrenergic blockade
Secondary outcomes (18)
Leukocyte count at the time points
Leukocyte count at the time points 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia, +1 day, +3 days and 1 week after of hypoglycaemia (e.g. Monocytes, granulocytes, lymphocytes).
Measured: 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia, +1 day, +3 days and 1 week after of hypoglycaemia
Ex vivo production of pro- and anti-inflammatory cytokines and chemokines
Ex vivo production of pro- and anti-inflammatory cytokines and chemokines after ex vivo stimulation of isolated leukocytes, including Tumor necrosis factor-α, Interleukin-6, Interleukin-10 and Interleukin-1β, 1β
Measured: 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia, +1 day, +3 days and 1 week after of hypoglycaemia
92 circulating inflammatory proteins
92 circulating inflammatory proteins using Olink Proteomics inflammation panel
Measured: 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia
Inflammatory plasma protein ( e.g. high-sensitive crp)
Inflammatory plasma protein using ELISA,(e.g high sensitive-crp)
Measured: 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia
Atherogenic parameters
Atherogenic parameters using ELISA including but not limited to, vascular endothelial cell adhesion molecule-1, vascular endothelial cell adhesion molecule-1, E-Selectin, P-selectin, Plasminogen activator inhibitor-1, Plasma Endothelin
Measured: 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia
Plasma levels of hormones
Plasma levels of hormones ( Cortisol, insulin, glucagon, growth-hormone, adrenaline, noradrenaline)
Measured: 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia
Amount of hypoglycaemic events measured by the blinded continuous glucose monitor
Amount of events
Measured: During the full study, 3 days before and 7 days after each investigational day
Variability measured by the blinded continuous glucose monitor
Variability of glucose expressed as a standard deviation of the mean glucose
Measured: During the full study, 3 days before and 7 days after each investigational day
Average glucose measured by the blinded continuous glucose monitor
Average glucose during the 10 days of measuring expressed as mmol/L
Measured: During the full study, 3 days before and 7 days after each investigational day
Time in range measured by the blinded continuous glucose monitor
Amount of time that glucose is between 3.8 and 10 mmol/L expressed as a percentage
Measured: During the full study, 3 days before and 7 days after each investigational day
Amount of plasma glycerol
Amount of plasma glycerol during and after hypoglycaemia
Measured: 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia
Amount of Non-esterified fatty acids
Amount of Non-esterified fatty acids (NEFAs) during and after hypoglycaemia
Measured: 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia
Untargeted metabolomics profiling
Measuring a panel of amino acids
Measured: 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia
Gene expression changes in leukocytes
Gene expression changes in leukocytes (e.g. using RNA sequencing, quantitative PCR)
Measured: 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia
Epigenetic changes in leukocytes
Epigenetic changes in leukocytes (e.g. using Assay for Transposase- Accessible Chromatin using sequencing (ATACseq), DNA methylation analysis)
Measured: 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia
Functional changes in monocytes
Functional changes in monocytes (e.g. using adhesion assays, differentiation experiments)
Measured: 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia
Adrenergic symptoms assessed using the validated Edinburgh Hypoglycaemia Score
Measured: 0, 30 minutes after euglycaemia, 30 minutes and 60 minutes during hypoglycaemia
Hypoglycaemia awareness using the modified Clarke score
Measured: At screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start28 Sep 2025
- Primary completion28 Sep 2025
- Study completion28 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- Potentially eligible adult ( 16 - 75 years) participants will be recruited through social media, the Radboudumc outpatient clinic and other advertisements. We will recruit a total of 24 individuals, i.e. 12 healthy participants and 12 participants with type 1 diabetes. Participants with type 1 diabetes will be twice ( as there are two investigational days) equipped with a blinded continuous glucose monitoring device (CGM) during the test, which will measure interstitial glucose levels for a total of 10 days.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cees Tack, MD, PhD, Principal investigator, Radboud University Medical Center (Radboudumc)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422494
- Sponsor's protocol ID
- 115142
- Acronym
- RAID-II
- Status last verified
- Jul 2025
- First submitted
- 8 May 2024
- Last updated
- 13 Aug 2026
- 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 repository accessible through the research team on demand. Starting around 6 months after publication.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Adrenergic System in Hypoglycaemia Induced Inflammatory Response in People With Type 1 Diabetes and People Without Type 1 Diabetes-RAID-II
- ClinicalTrials.gov ID
- NCT06422494
- Acronym / sponsor ID
- RAID-II / 115142
- Conditions
- Diabetes Mellitus, Type 1, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 28 Sep 2025 (actual)
- Primary completion
- 28 Sep 2025 (actual)
- Study completion
- 28 Sep 2025 (actual)
- First posted
- 21 May 2024 (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 goal of this trial is to study the effect that adrenaline has on the immune reaction seen during a low blood sugar. People with type 1 diabetes do not produce their own insulin. The cells in the pancreas that produce insulin are destroyed. People with type 1 diabetes require daily insulin administration. As a consequence of this insulin therapy the blood sugar can dip too low, causing symptoms such as confusion, irritation and tiredness. This is called hypoglycaemia. Hypoglycaemia has been associated with an increased risk for cardiovascular disease such as heart attacks. During hypoglycaemia the immune system is activated. The immune system consists of white blood cells which produce cytokines, these are proteins used to kill pathogens such as bacteria. During hypoglycaemia there are no pathogens but the cytokines are still produced, leading to unwanted damage. A previous study performed by our research group showed that the immune system activation caused by hypoglycaemia is associated with the stress hormone adrenaline. Adrenaline is released by the body in moments of stress such as during running or bungee jumping. Adrenaline is also released by the body during hypoglycaemia to increase the sugar level. Our hypothesis is that adrenaline activates the immune system during hypoglycaemia. Adrenaline acts in the body through two receivers, these are called alpha and beta receptors. These are present on almost all cells in the body especially on the immune cells. With the study we want to study the situation where there is a hypoglycaemia without the adrenaline. We will achieve this by lowering the blood sugar in participants. During the low blood sugar we will administer two drugs, which will attach themselves to the adrenaline receivers, the alpha and beta receptor. With this method we hope to block the adrenaline effects and with that block the immune response caused by adrenaline.
Detailed description
Rationale: Hypoglycaemia has shown to cause a sustained pro-inflammatory response which could promote a pro-atherogenic state and explain the association between hypoglycaemia and cardiovascular events. This pro-inflammatory response has been linked to the adrenaline response to hypoglycaemia. Adrenergic blockade with α and β adrenergic receptor antagonists (ARA) has shown to blunt the leukocyte response after hypoglycaemia induction and adrenaline administration. Whether and to what degree a combined blockade blunts the hypoglycaemia induced pro-inflammatory response is unknown.
Objective: to examine the effect of adrenergic inhibition on the hypoglycaemia induced inflammatory response (e.g. leukocyte phenotype, cytokines, inflammatory proteins) by performing a hyperinsulinaemic hypoglycaemic glucose clamp alongside infusion of α-ARA and β-ARA. Secondary objectives consist of the effect of adrenergic blockade during hypoglycaemia on atherogenic parameters and glucose metrics ( e.g. time in range).
Study design: Intervention study with a cross-over design
Study population: Potentially eligible adult ( 16 - 75 years) participants will be recruited through social media, the Radboudumc outpatient clinic and other advertisements. We will recruit a total of 24 individuals, i.e. 12 healthy participants and 12 participants with type 1 diabetes. Participants with type 1 diabetes will be twice ( as there are two investigational days) 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 undergo a hyperinsulinaemic hypoglycaemic glucose clamp ( nadir 2.8 mmol/L). During the clamp the participants will be randomized to receive an infusion of saline or an infusion of phentolamine and propranolol. This will be done using a cross-over design. The participants will undergo both the saline and adrenergic blockade.
Main study parameters/endpoints: The main study parameter will be the monocyte count after 60 minutes hyperinsulinaemic hypoglycaemic clamp and adrenergic blockade during the clamp.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Potentially eligible adult ( 16 - 75 years) participants will be recruited through social media, the Radboudumc outpatient clinic and other advertisements. We will recruit a total of 24 individuals, i.e. 12 healthy participants and 12 participants with type 1 diabetes. Participants with type 1 diabetes will be twice ( as there are two investigational days) equipped with a blinded continuous glucose monitoring device (CGM) during the test, which will measure interstitial glucose levels for a total of 10 days.
| Arm | Type | Receives |
|---|---|---|
| Participants without type 1 diabetes | Active comparator | Drug: hyperinsulinaemic hypoglycaemic clamp, Drug: Propranolol Hydrochloride 1 MG/ML, Drug: PhentolamineThe participants without type 1 diabetes |
| Participants with type 1 diabetes | Active comparator | Drug: hyperinsulinaemic hypoglycaemic clamp, Drug: Propranolol Hydrochloride 1 MG/ML, Drug: PhentolamineParticipants with type 1 diabetes |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Overall inclusion criteria:
- Insulin treatment according to basal-bolus insulin regimen (injections or insulin pump)
- Duration of diabetes > 1 year
- HbA1c < 100 mmol/mol,
Key exclusion criteria (13 listed)
- Any event of cardiovascular disease in the past 5 years (e.g. myocardial infarction, stroke, symptomatic peripheral arterial disease)
- Pregnancy or breastfeeding or unwillingness to undertake measures for birth control
- Active epilepsy ( with the need for treatment)
- Allergy for sulphite
- Active asthma with use of β2-bronchodilators or obstructive lung disease
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 |
|---|---|---|
| hyperinsulinaemic hypoglycaemic clampInsulin will be infused at a continuous rate of 60 mU∙m-2 ∙min-1 and glucose 20% will be infused at a variable rate, aiming for stable plasma glucose levels of 5.0 mmol/L. The infusion rate of glucose will be adjusted by plasma glucose levels, measured at 5-minute intervals. After 30 minutes of stable euglycaemia, plasma glucose levels will be allowed to drop gradually to 2.8 mmol/L and will be maintained at this level for 60 minutes. Then, insulin infusion and adrenergic blockade infusions will be stopped. Glucose infusion will be increased and then tapered until stable euglycaemia plasma levels are reached. | Drug | Participants with type 1 diabetes, Participants without type 1 diabetes |
| Propranolol Hydrochloride 1 MG/MLWhen euglycaemic level of 5.0mmol/L is achieved we will start the adrenergic blockade which will continue throughout euglycaemia and hypoglycaemia. The participants will be administered a bolus of phentolamine of 70µg/kg followed by a dose of 7.0µg/kg/min continuous infusion and a bolus of propranolol of 14µg/kg followed by a dose of 1.4µg/kg/min. | Drug | Participants with type 1 diabetes, Participants without type 1 diabetes |
| PhentolamineWhen euglycaemic level of 5.0mmol/L is achieved we will start the adrenergic blockade which will continue throughout euglycaemia and hypoglycaemia. The participants will be administered a bolus of phentolamine of 70µg/kg followed by a dose of 7.0µg/kg/min continuous infusion and a bolus of propranolol of 14µg/kg followed by a dose of 1.4µg/kg/min. | Drug | Participants with type 1 diabetes, Participants without type 1 diabetes |
Primary outcome
Monocyte count after 60 minutes of hypoglycaemia and adrenergic blockade
Time frame: After 60 minutes of hypoglycaemia and adrenergic blockade
The number of monocytes following 60 minutes hypoglycaemia and adrenergic blockade compared to baseline. Adrenergic blockade using Phentolamine and Propranolol intravenously. Expressed in 10^3/µl measured using a sysmex machine.
18 secondary outcomes
Leukocyte count at the time points
Time frame: 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia, +1 day, +3 days and 1 week after of hypoglycaemia
Ex vivo production of pro- and anti-inflammatory cytokines and chemokines
Time frame: 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia, +1 day, +3 days and 1 week after of hypoglycaemia
92 circulating inflammatory proteins
Time frame: 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia
Inflammatory plasma protein ( e.g. high-sensitive crp)
Time frame: 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia
Atherogenic parameters
Time frame: 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia
Plasma levels of hormones
Time frame: 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia
Amount of hypoglycaemic events measured by the blinded continuous glucose monitor
Time frame: During the full study, 3 days before and 7 days after each investigational day
Variability measured by the blinded continuous glucose monitor
Time frame: During the full study, 3 days before and 7 days after each investigational day
Average glucose measured by the blinded continuous glucose monitor
Time frame: During the full study, 3 days before and 7 days after each investigational day
Time in range measured by the blinded continuous glucose monitor
Time frame: During the full study, 3 days before and 7 days after each investigational day
Amount of plasma glycerol
Time frame: 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia
Amount of Non-esterified fatty acids
Time frame: 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia
Untargeted metabolomics profiling
Time frame: 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia
Gene expression changes in leukocytes
Time frame: 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia
Epigenetic changes in leukocytes
Time frame: 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia
Functional changes in monocytes
Time frame: 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia
Adrenergic symptoms assessed using the validated Edinburgh Hypoglycaemia Score
Time frame: 0, 30 minutes after euglycaemia, 30 minutes and 60 minutes during hypoglycaemia
Hypoglycaemia awareness using the modified Clarke score
Time frame: At screening
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 13 Aug 2026.
- Individual participant dataSharing planned: Yes. We will share the study protocol using a data repository accessible through the research team on demand. Starting around 6 months after publication.
Related trials for Diabetes Mellitus, Type 1
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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 hyperinsulinaemic hypoglycaemic clamp, Propranolol Hydrochloride 1 MG/ML and Phentolamine in people with Diabetes Mellitus, Type 1 and Inflammation, run by Radboud University Medical Center 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 11 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 13 Aug 2026. 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 after 60 minutes of hypoglycaemia and adrenergic blockade (time frame: After 60 minutes of hypoglycaemia and adrenergic blockade). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2026.