Trial · NCT06422494
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Monocyte count after 60 minutes of hypoglycaemia and adrenergic blockade | 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. |
| Secondary | 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 | 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). |
| Secondary | Ex vivo production of pro- and anti-inflammatory cytokines and chemokines | 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 after ex vivo stimulation of isolated leukocytes, including Tumor necrosis factor-α, Interleukin-6, Interleukin-10 and Interleukin-1β, 1β |
| Secondary | 92 circulating inflammatory proteins | 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia | 92 circulating inflammatory proteins using Olink Proteomics inflammation panel |
| Secondary | Inflammatory plasma protein ( e.g. high-sensitive crp) | 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia | Inflammatory plasma protein using ELISA,(e.g high sensitive-crp) |
| Secondary | Atherogenic parameters | 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia | 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 |
| Secondary | Plasma levels of hormones | 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia | Plasma levels of hormones ( Cortisol, insulin, glucagon, growth-hormone, adrenaline, noradrenaline) |
| Secondary | Amount of hypoglycaemic events measured by the blinded continuous glucose monitor | During the full study, 3 days before and 7 days after each investigational day | Amount of events |
| Secondary | Variability measured by the blinded continuous glucose monitor | During the full study, 3 days before and 7 days after each investigational day | Variability of glucose expressed as a standard deviation of the mean glucose |
| Secondary | Average glucose measured by the blinded continuous glucose monitor | During the full study, 3 days before and 7 days after each investigational day | Average glucose during the 10 days of measuring expressed as mmol/L |
| Secondary | Time in range measured by the blinded continuous glucose monitor | During the full study, 3 days before and 7 days after each investigational day | Amount of time that glucose is between 3.8 and 10 mmol/L expressed as a percentage |
| Secondary | Amount of plasma glycerol | 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia | Amount of plasma glycerol during and after hypoglycaemia |
| Secondary | Amount of Non-esterified fatty acids | 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia | Amount of Non-esterified fatty acids (NEFAs) during and after hypoglycaemia |
| Secondary | Untargeted metabolomics profiling | 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia | Measuring a panel of amino acids |
| Secondary | Gene expression changes in leukocytes | 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia | Gene expression changes in leukocytes (e.g. using RNA sequencing, quantitative PCR) |
| Secondary | Epigenetic changes in leukocytes | 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia | Epigenetic changes in leukocytes (e.g. using Assay for Transposase- Accessible Chromatin using sequencing (ATACseq), DNA methylation analysis) |
| Secondary | Functional changes in monocytes | 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia | Functional changes in monocytes (e.g. using adhesion assays, differentiation experiments) |
| Secondary | Adrenergic symptoms assessed using the validated Edinburgh Hypoglycaemia Score | 0, 30 minutes after euglycaemia, 30 minutes and 60 minutes during hypoglycaemia | |
| Secondary | Hypoglycaemia awareness using the modified Clarke score | At screening | |
| Other | HbA1c expressed in mmol/L | At screening |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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