Effects of low oxygen levels on kidney function in healthy individuals and diabetes patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates how acute hypoxia affects renal hemodynamics in healthy volunteers, patients with diabetes, and those with diabetic kidney disease. Participants will be subjected to hypoxia administration to assess changes in kidney function, specifically focusing on renal clearance. The study aims to better understand the implications of low oxygen levels on kidney health, particularly in individuals with diabetes and diabetic nephropathies. By comparing responses across different groups, the research seeks to identify potential risks and mechanisms involved in kidney disease progression.

Why it matters

Who can join: the full rules

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

Where it's running

• Centre Investigation Clinique CIC1402 - CHU Poitiers
  Poitiers, France Recruiting

Study contacts

• Principal investigator: Pierre Jean SAULNIER, MD PhD — CHU Poitiers
• Study coordinator: Emilie RABOIS, MSc
• Email: emilie.rabois@chu-poitiers.fr
• Phone: +330549444686

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.