Investigating how adrenaline affects inflammation during low blood sugar in people with and without type 1 diabetes
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
NA · Radboud University Medical Center · NCT06422494
This study is testing how adrenaline affects inflammation during low blood sugar in people with type 1 diabetes and healthy individuals to see if there are differences in their immune responses.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 16 Years to 75 Years |
| Sex | All |
| Sponsor | Radboud University Medical Center (other) |
| Locations | 1 site (Nijmegen, Gelderland) |
| Trial ID | NCT06422494 on ClinicalTrials.gov |
What this trial studies
This trial aims to explore the role of the adrenergic system in the inflammatory response triggered by hypoglycaemia in individuals with type 1 diabetes compared to healthy individuals. It will utilize a hyperinsulinaemic hypoglycaemic clamp method alongside the administration of adrenergic receptor antagonists to assess their impact on immune response markers such as leukocyte phenotype and cytokines. The study will recruit 24 participants, including 12 with type 1 diabetes and 12 healthy controls, to undergo two investigational days with continuous glucose monitoring. The findings could provide insights into the relationship between hypoglycaemia, inflammation, and cardiovascular risk.
Who should consider this trial
Good fit: Ideal candidates include adults aged 16 to 75 with type 1 diabetes who have been on insulin therapy for over a year and meet specific health criteria.
Not a fit: Patients with a history of cardiovascular disease, pregnancy, or certain respiratory conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for hypoglycaemia in patients with type 1 diabetes, potentially reducing their risk of cardiovascular complications.
How similar studies have performed: Previous studies have indicated that adrenergic blockade can mitigate inflammatory responses, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * 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, Exclusion Criteria: * 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) * 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
Where this trial is running
Nijmegen, Gelderland
- Radboud University Medical Center, Nijmegen, Netherlands — Nijmegen, Gelderland, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Cees Tack, MD, PhD — Radboud University Medical Center (Radboudumc)
- Study coordinator: Ilyas Mustafajev, M.D.
- Email: ilyas.mustafajev@radboudumc.nl
- Phone: 0629669369
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Mellitus, Type 1, Inflammation