Effect of Acute Hypoxia on Renal Hemodynamic in Healthy Volunteers, Patients With Diabetes and Patients With Diabetes and Kidney Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPoitiers University Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Hypoxia administration study group

    Other intervention

    Acute 2-hour hypoxia (14.5%FiO2 corresponding to 3000m altitude)

  • Renal clairance study

    Combination product

    Assessment 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

30 Participants
are divided into 1 treatment group
Group A: acute hypoxiaOther 2 interventions

Trial outcomes

Primary outcomes

1

Effective Renal Plasma Flow (ERPF)

Measured by PAH clearance

Time frame
5 hours
2

Glomerular Filtration Rate

Measured by Iohexol Clearance

Time frame
5 hours

Secondary outcomes

1

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.

Time frame
8 days
2

blood pressure

mean arterial pressure

Time frame
5 hours
3

heart rate

heart rate

Time frame
5 hours
4

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.

Time frame
5 hours

Other outcomes

1

Renal Oxygenation Availability

Blood oxygen level dependent (BOLD) MRI

Time frame
60 minutes
2

Cardiac Oxygenation Availability

Blood oxygen level dependent (BOLD) MRI

Time frame
60 minutes

Sponsors and contacts

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