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

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

This study is testing how low oxygen levels affect kidney function in healthy people and those with diabetes to see if there are different risks for kidney health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Poitiers University Hospital (Academic / other)
• Locations: 1 site (Poitiers)
• Trial ID: NCT06846034 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include healthy volunteers aged 18-40, and patients aged 35-75 with type 2 diabetes, either with or without diabetic kidney disease.

Not a fit: Patients with a history of respiratory diseases or those with proliferative diabetic retinopathy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for kidney health in diabetic patients.

How similar studies have performed: While the specific approach of this study may be novel, similar studies have shown that understanding renal responses to hypoxia can provide insights into diabetic kidney disease.

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

Where this trial is running

Poitiers

• 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

Conditions Diabetes; Diabetic Kidney Disease; Hypoxia; Healthy Volunteer; Diabetic Nephropathies