Actively Recruiting
Effect of Acute Hypoxia on Renal Hemodynamic in Healthy Volunteers, Patients With Diabetes and Patients With Diabetes and Kidney Disease: Pilot Study
Led by Poitiers University Hospital · Updated on 2025-04-09
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of acute hypoxia on kidney blood flow and function in healthy volunteers, patients with type 2 diabetes, and those with diabetic kidney disease. Diabetes is a growing health concern worldwide, often leading to kidney problems that current screening methods may detect only in later stages. This research aims to explore early changes in kidney function related to low oxygen levels, which play a role in diabetic kidney disease progression. Participants undergo two exposure periods: a 3-hour normal oxygen breathing phase and a 2-hour hypoxia phase at oxygen levels simulating 3000 meters altitude. Kidney function is assessed using diagnostic agents measuring effective renal plasma flow and glomerular filtration rate. The study also collects data on mitochondrial metabolites, blood pressure, heart rate, oxygen saturation, and symptoms during the sessions. Throughout the study, participants will be monitored with blood tests, questionnaires, and imaging scans to evaluate kidney function and overall response to hypoxia. The main outcomes measured over 5 hours include kidney filtration rates and plasma flow. Secondary measures such as blood pressure and oxygen saturation are also recorded. The study is expected to last several hours per participant, with follow-up assessments extending up to 8 days to capture metabolic changes.
CONDITIONS
Brief Title
Effect of Acute Hypoxia on Renal Hemodynamic in Healthy Volunteers, Patients With Diabetes and Patients With Diabetes and Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- No history of respiratory diseases
- Affiliated with or beneficiary of the French social security scheme
- Signed informed consent
- For healthy volunteers: age 18 to 40 years, no diabetes, no acute or long-term drug use except contraception, BMI between 18.5 and 29.9 kg/m2, eGFR above 60 ml/min/1.73m2, albumin-to-creatinine ratio below 3 mg/mmol
- For patients with type 2 diabetes: diagnosed according to ADA criteria, age 35 to 75 years, stable diabetes and/or antihypertension treatment for at least 2 months, no proliferative diabetic retinopathy
- For patients with type 2 diabetes without kidney disease: eGFR above 60 ml/min/1.73m2, albumin-to-creatinine ratio below 3 mg/mmol
- For patients with diabetic kidney disease: eGFR between 45 and 60 ml/min/1.73m2 and/or albumin-to-creatinine ratio 3 mg/mmol or higher
You will not qualify if you...
- Active smoking
- Contraindication to any study agents (PAH, iohexol, gadolinium)
- Contraindication to cardiac MRI, renal MRI, or respiratory tests
- History of acute coronary syndrome or coronary revascularization
- Recent (less than 6 months) heart failure hospitalization, stroke, or transient ischemic attack
- Severe unstable hypertension (systolic ≥ 180 mmHg or diastolic ≥ 110 mmHg)
- Resting oxygen saturation below 95% at baseline
- Any disease or condition that may interfere with safety or study completion
- History of severe mountain sickness
- Use of SGLT2 inhibitors
- Participation in another clinical research study
- Pregnant or breastfeeding women, or women of childbearing age without effective contraception
- Persons with enhanced protection under French law
- Persons under psychiatric care unable to give consent
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - One day
Participants undergo a 3-hour normoxia period followed by a 2-hour acute hypoxia exposure at approximately 3000m altitude. Renal clearance is assessed by measuring glomerular filtration rate and effective renal plasma flow using diagnostic agents.
1 treatment visit (in-person)
Duration - 8 days
Participants are monitored for changes in circulating and urinary mitochondrial metabolites and vital signs after treatment.
Multiple follow-up assessments during the 8 days after treatment
Trial Site Locations
Total: 1 location
1
Centre Investigation Clinique CIC1402 - CHU Poitiers
Poitiers, France
Actively Recruiting
Research Team
E
Emilie RABOIS, MSc
C
Céline DELETAGE METREAU, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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