About this trial
Diabetes mellitus is a non-transmissible disease whose incidence is growing worldwide .
This pathology is defined by a chronic hyperglycaemia linked to a deficiency of either insulin secretion or its action or both. This increased prevalence is linked to the growing of the obese population on one hand, and to the ageing of the population, on the other hand, which is associated with an increased prevalence of metabolic diseases. The number of patients with diabetes, particularly type 2 diabetes (T2D) is regularly increasing. In France, the prevalence of diabetes is 4- 6% of the adult population.
Diabetic kidney disease (DKD) is a growing public health problem and therefore constitutes a major factor in progressive kidney disease. DKD has become the leading cause of end stage kidney disease (ESKD), requiring dialysis or transplantation.
Current routine screening for DKD is limited to detecting of impaired glomerular filtration rate (GFR) and/or elevated albuminuria, typically manifests in later stages of DKD. Therefore, the current methods to screen for DKD lack the resolution to capture the earliest functional changes associated with DKD.
Chronic renal hypoxia plays a crucial role in the development and progression of DKD and may affect Renal hemodynamic.
The aim to assess the feasibility of the measure of hypoxa-induced renal hemodynamics parameters.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
No history of respiratory diseases
Affiliated person or beneficiary of the French social security scheme.
signed informed consent
[18; 40] years old
Disqualifiers
Active smoking
Contraindication to any of the agent (PAH, or iohexol or gadolinium) used in the study.
Contraindication to cardiac MRI, renal MRI, respiratory tests,
History acute coronary syndrome or coronary revascularization
Trial design
Single group
Treatments tested in this trial
Hypoxia administration study group
Other interventionAcute 2-hour hypoxia (14.5%FiO2 corresponding to 3000m altitude)
Renal clairance study
Combination productAssessment of renal clearance by measuring Glomerular Filtration Rate (GFR) after two agents infusion: * Aminohippurate Sodium (or or para-aminohippuric acid \[PAH\]) Inj 20% Diagnostic agent used to measure effective renal plasma flow (ERPF) * Iohexol Inj 300 MG/ML Diagnostic agent used to measure glomerular filtration rate (GFR)
Treatment groups
Trial outcomes
Primary outcomes
Effective Renal Plasma Flow (ERPF)
Measured by PAH clearance
Glomerular Filtration Rate
Measured by Iohexol Clearance
Secondary outcomes
circulating and urinary mitochondrial metabolites
To investigate change of blood or urine metabolites : 2-ethyl 3-OH propionate, 3-hydroxy propionate, 3-hydroxy isovalerate, 3-methyl-crotonyl glycine, 3-hydroxy isobutyrate, Tiglyglycine, Aconitic acid, Citric acid, Glycolic acid, Homovanillic acid, Uracil, 3-methyl adipic acid.
blood pressure
mean arterial pressure
heart rate
heart rate
Lake Louise Questionnaire
The Lake Louise Scoring was developed to assess the symptoms of acute mountain sickness in adults. It consist of 4 questions, each rated on a likert-type scale with 0-3 response options. Lower scores men a better outcome.
Other outcomes
Renal Oxygenation Availability
Blood oxygen level dependent (BOLD) MRI
Cardiac Oxygenation Availability
Blood oxygen level dependent (BOLD) MRI
Sponsors and contacts
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