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

Recruiting now · Not applicable

Conditions studied: Diabetes, Diabetic Kidney Disease, Hypoxia, Healthy Volunteer, Diabetic Nephropathies

In brief

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.

Key facts

Study ID

NCT06846034

Run by

Poitiers University Hospital

People needed

30

Starts

2025-02-13

Expected to finish

2026-09-01

Last updated by the study team

2025-04-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• For all participant :
• No history of respiratory diseases
• Affiliated person or beneficiary of the French social security scheme.
• signed informed consent
• Group 1 ( For healthy volunteers):
• [18; 40] years old
• No history of diabetes
• No acute/long term > 3 months drug use except contraception
• BMI: [18,5 - 29,9]kg/m2
• eGFR > 60ml/min/1.73m2
• Normal to midly increased albuminuria: defined as ACR < 3 mg/mmol
• For all the patients with T2D (group 2 and 3):
• Diagnosed T2D according to ADA criteria
• [35; 75] years old
• Stable treatment of diabetes and/or antihypertension for at least 2 months prior to inclusion
• 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

You may not qualify if…

• For all participants:
• Active smoking
• Contraindication to any of the agent (PAH, or iohexol or gadolinium) used in the study.
• Contraindication to cardiac MRI, renal MRI, respiratory tests,
• History acute coronary syndrome or coronary revascularization
• Recent (<6 months) history of: Heart failure requiring hospitalisation or Stroke or transient ischemic neurologic disorder
• Severe unstable hypertension (≥180 mmHg systolic or ≥110 mmHg diastolic blood pressure)
• Resting oxygen saturation <95% at baseline
• 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.
• History of severe mountain sickness (dizziness, headache, nausea/vomiting and incapaciting fatigue)
• Consumption of SGLT2 inhibitors
• Concurrent participation in another clinical research study
• Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception
• Persons benefiting from enhanced protection under french national law
• Persons under psychiatric care who are unable to give their consent

Where it is running

• Centre Investigation Clinique CIC1402 - CHU Poitiers — Poitiers, France (enrolling)

Full record on ClinicalTrials.gov

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