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Clinical Trial Details

Trial ID: L1846
Source ID: NCT04193566
Associated Drug: Forxiga
Title: Acute Effects of SGLT2 Inhibition on Renal Oxygenation and Autonomic Function in Type 1 Diabetes
Acronym: Astronaut
Status: COMPLETED
Study Results: NO
Results:
Conditions: Nephropathy|Hypoxia|Mitochondrial Alteration|Type 1 Diabetes|Autonomic Neuropathy, Diabetic
Interventions: DRUG: Forxiga
Outcome Measures: Primary: Change in Renal oxygenation, Blood Oxygen Level Dependent (BOLD) Magnetic Resonance Imaging (MRI) assessing the transverse relaxation time of atomic nuclei in the tissue (T2\*) in miliseconds (ms)., From baseline to +3 hours from intervention|Change in Renal oxygenation, BOLD MRI assessing the transverse relaxation time of atomic nuclei in the tissue (T2\*) in miliseconds (ms)., From baseline to +6 hours from intervention | Secondary: Change in renal cortical and medullary perfusion, Renal tissue perfusion can be measured noninvasively with MRI using arterial spin labelling (ASL). It is measured in mL/g/min., From baseline to +3 hours from intervention|Change in renal cortical and medullary perfusion, Renal tissue perfusion can be measured with MRI using arterial spin labelling (ASL). It is measured in mL/g/min., From baseline to +6 hours from intervention|Change in renal artery flow, Renal artery flow can be measured by using phase contrast (PC) MRI. It is measured in mL/min., From baseline to +3 hours from intervention|Change in renal artery flow, Renal artery flow can be measured by using phase contrast (PC) MRI. It is measured in mL/min., From baseline to +6 hours from intervention|Change in renal oxygen consumption, Renal oxygen consumption can be measured using Q-flow combined with BOLD MRI. It is measured in pmol/min/microgram protein., From baseline to +3 hours from intervention|Change in renal oxygen consumption, Renal oxygen consumption can be measured using Q-flow combined with BOLD MRI. pmol/min/microgram protein, From baseline to +6 hours from intervention|Change in peripheral capillary oxygen saturation (SpO2), Pulse oximetry on index finger of the right hand. Estimates blood oxygen saturation from capillary blood. Measured in %., From baseline to +3 hours from intervention|Change in peripheral capillary oxygen saturation (SpO2), Pulse oximetry on index finger of the right hand. Estimates blood oxygen saturation from capillary blood. Measured in %., From baseline to +6 hours from intervention|Change in blood oxygen partial pressure (PaO2), Blood gas analysis on arterial blood. Measured in kPa., From baseline to +3 hours from intervention|Change in blood oxygen partial pressure (PaO2), Blood gas analysis on arterial blood. Measured in kPa., From baseline to +6 hours from intervention|Change in arterial blood oxygen saturation, Blood gas analysis on arterial blood. Measured in %., From baseline to +3 hours from intervention|Change in arterial blood oxygen saturation, Blood gas analysis on arterial blood. Measured in %., From baseline to +6 hours from intervention|Change in Peripheral Blood Monocyte mitochondrial function, Seahorse X96 analyzer. Analyzes the oxygen consumption rate (OCR), measured in pMoles/min., From baseline to +12 hours from intervention|Change in levels of circulating inflammatory markers, Commercially available panel from the company Olink. Includes 92 biomarkers. Information on the panel can be found here: https://www.olink.com/products/inflammation/#., From baseline to +12 hours from intervention|Change in baroreflex sensitivity, Calculated from continous blood pressure and the distance between the R-waves in a continuous ecg. Baroreflex sensitivity describes how much heart-rate changes when blood pressure changes. Assessment of baroreflex sensitivity is done in a measurement of 5 minutes. The unit is ms/mmHg., From baseline to +12 hours from intervention
Sponsor/Collaborators: Sponsor: Steno Diabetes Center Copenhagen | Collaborators: Glostrup University Hospital, Copenhagen|Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2020-02-01
Completion Date: 2021-01-01
Results First Posted:
Last Update Posted: 2021-02-03
Locations: Steno Diabetes Center Copenhagen, Gentofte, 2820, Denmark
URL: https://clinicaltrials.gov/show/NCT04193566