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

Status: Recruiting
Location: See location...
Intervention Type: Combination product, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

‣ For all participant :

⁃ No history of respiratory diseases

⁃ Affiliated person or beneficiary of the French social security scheme.

⁃ signed informed consent

‣ Group 1 ( For healthy volunteers):

⁃ \[18; 40\] years old

⁃ No history of diabetes

⁃ No acute/long term \> 3 months drug use except contraception

⁃ BMI: \[18,5 - 29,9\]kg/m2

⁃ eGFR \> 60ml/min/1.73m2

⁃ Normal to midly increased albuminuria: defined as ACR \< 3 mg/mmol

‣ For all the patients with T2D (group 2 and 3):

⁃ Diagnosed T2D according to ADA criteria

⁃ \[35; 75\] years old

⁃ Stable treatment of diabetes and/or antihypertension for at least 2 months prior to inclusion

⁃ No proliferative diabetic retinopathy

‣ Group 2 - For patients with T2D and no DKD:

• eGFR \> 60ml/min/1.73m2 and

• Normal to midly increased albuminuria: defined as ACR \< 3 mg/mmol

‣ Group 3 - For patients with DKD:

• eGFR \[45-60 ml/min/1.73m2\] and/or

• Moderately to severely increased ACR ≥ 3 mg/mmol

Locations
Other Locations
France
Centre Investigation Clinique CIC1402 - CHU Poitiers
RECRUITING
Poitiers
Contact Information
Primary
Emilie RABOIS, MSc
emilie.rabois@chu-poitiers.fr
+330549444686
Backup
Céline DELETAGE METREAU, PhD
Celine.DELETAGE-METREAU@chu-poitiers.fr
Time Frame
Start Date: 2025-02-13
Estimated Completion Date: 2026-09
Participants
Target number of participants: 30
Treatments
Other: acute hypoxia
The participant will be exposed to 2 sequences : a 3-hour normoxia period and then a 2-hour hypoxia (FiO2=14.26% corresponding to 3000m altitude) period.
Sponsors
Leads: Poitiers University Hospital

This content was sourced from clinicaltrials.gov