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

NCT ID: NCT06846034

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-13
• Study Completion Date: 2026-09-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Hypoxia administration study group

Intervention Type: OTHER

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

Renal clairance study

Intervention Type: 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)

Interventions

Hypoxia administration study group

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

Intervention Type: OTHER

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)

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

For all participant :

1. No history of respiratory diseases

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

3. signed informed consent

Group 1 ( For healthy volunteers):

1. [18; 40] years old

2. No history of diabetes

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

4. BMI: [18,5 - 29,9]kg/m2

5. eGFR > 60ml/min/1.73m2

6. Normal to midly increased albuminuria: defined as ACR < 3 mg/mmol

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

1. Diagnosed T2D according to ADA criteria

2. [35; 75] years old

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

4. 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

Exclusion Criteria

For all participants:

1. Active smoking

2. Contraindication to any of the agent (PAH, or iohexol or gadolinium) used in the study.

3. Contraindication to cardiac MRI, renal MRI, respiratory tests,

4. History acute coronary syndrome or coronary revascularization

5. Recent (<6 months) history of: Heart failure requiring hospitalisation or Stroke or transient ischemic neurologic disorder

6. Severe unstable hypertension (≥180 mmHg systolic or ≥110 mmHg diastolic blood pressure)

7. Resting oxygen saturation <95% at baseline

8. Any concomitant disease or condition that may interfere with the safety or the possibility for the patient to comply with or complete the study protocol.

9. History of severe mountain sickness (dizziness, headache, nausea/vomiting and incapaciting fatigue)

10. Consumption of SGLT2 inhibitors

11. Concurrent participation in another clinical research study

12. Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception

13. Persons benefiting from enhanced protection under french national law

14. Persons under psychiatric care who are unable to give their consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Jean SAULNIER, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Poitiers

Locations

Centre Investigation Clinique CIC1402 - CHU Poitiers

Poitiers, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Emilie RABOIS, MSc

Role: CONTACT

emilie.rabois@chu-poitiers.fr

+330549444686

Céline DELETAGE METREAU, PhD

Role: CONTACT

Celine.DELETAGE-METREAU@chu-poitiers.fr

Facility Contacts

Emilie RABOIS, MSc

Role: primary

emilie.rabois@chu-poitiers.fr

+33(0)549444689

Other Identifiers

DIAKIPOX

Identifier Type: -

Identifier Source: org_study_id