Actively Recruiting
Effect of Acute Hypoxia on Renal Hemodynamic in Healthy Volunteers, Patients With Diabetes and Patients With Diabetes and Kidney Disease
Led by Poitiers University Hospital · Updated on 2025-04-09
30
Participants Needed
1
Research Sites
80 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 history of diabetes for healthy volunteers
- No acute or long-term drug use longer than 3 months except contraception for healthy volunteers
- BMI between 18.5 and 29.9 kg/m2 for healthy volunteers
- eGFR greater than 60 ml/min/1.73m2 for healthy volunteers
- Normal to mildly increased albuminuria (ACR less than 3 mg/mmol) for healthy volunteers
- For patients with type 2 diabetes: diagnosed by ADA criteria
- Age 35 to 75 years for patients with diabetes
- Stable diabetes and/or antihypertension treatment for at least 2 months before inclusion
- No proliferative diabetic retinopathy
- For patients with diabetes without kidney disease: eGFR greater than 60 ml/min/1.73m2 and ACR less than 3 mg/mmol
- For patients with diabetic kidney disease: eGFR between 45 and 60 ml/min/1.73m2 and/or moderately to severely increased ACR (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 requiring hospitalization, stroke, or transient ischemic attack
- Severe unstable hypertension (systolic 180 mmHg or higher, diastolic 110 mmHg or higher)
- Resting oxygen saturation below 95% at baseline
- Any disease or condition interfering with study safety or completion
- History of severe mountain sickness
- Use of SGLT2 inhibitors
- Participation in another clinical research study
- Pregnant or breastfeeding women or women without effective contraception
- Persons with enhanced protection under French national law
- Persons under psychiatric care unable to give consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centre Investigation Clinique CIC1402 - CHU Poitiers
Poitiers, France
Actively Recruiting
Research Team
E
Emilie RABOIS, MSc
CONTACT
C
Céline DELETAGE METREAU, PhD
CONTACT
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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