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

Launched by POITIERS UNIVERSITY HOSPITAL · Feb 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how low oxygen levels (called hypoxia) affect kidney function in different groups of people: healthy volunteers, patients with type 2 diabetes who do not have kidney disease, and patients with type 2 diabetes who also have kidney disease. The researchers want to understand how these changes in oxygen levels can impact the kidneys, especially since diabetes can lead to kidney problems over time.

To participate, healthy volunteers need to be between 18 and 40 years old and have no history of diabetes. Patients with type 2 diabetes must be between 35 and 75 years old, with certain health criteria based on their kidney function. Participants will receive a thorough screening to ensure they meet the criteria and are safe to join. Throughout the study, participants can expect to undergo tests related to kidney health and oxygen levels, helping researchers learn more about the early signs of kidney disease linked to diabetes.

Gender

ALL

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