NCT06846034

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Diabetes
• Diabetic Kidney Disease
• Hypoxia
• Healthy Volunteer
• Diabetic Nephropathies

Interventions

Type	Name	Description
OTHER	Hypoxia administration study group	Acute 2-hour hypoxia (14.5%FiO2 corresponding to 3000m altitude)
COMBINATION_PRODUCT	Renal clairance study	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)

Timeline

• Start date: 2025-02-13
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2025-02-25
• Last updated: 2025-04-09

Locations

1 site across 1 country: France