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

Last updated: April 7, 2025
Sponsor: Poitiers University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetic Gastroparesis

Diabetic Macular Edema

Diabetes And Hypertension

Treatment

Hypoxia administration study group

Renal clairance study

Clinical Study ID

NCT06846034
DIAKIPOX
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 toinclusion

  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

Exclusion Criteria:

For all participants:

  1. Active smoking

  2. Contraindication to any of the agent (PAH, or iohexol or gadolinium) used in thestudy.

  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 ortransient ischemic neurologic disorder

  6. Severe unstable hypertension (≥180 mmHg systolic or ≥110 mmHg diastolic bloodpressure)

  7. Resting oxygen saturation <95% at baseline

  8. Any concomitant disease or condition that may interfere with the safety or thepossibility for the patient to comply with or complete the study protocol.

  9. History of severe mountain sickness (dizziness, headache, nausea/vomiting andincapaciting 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 effectivecontraception

  13. Persons benefiting from enhanced protection under french national law

  14. Persons under psychiatric care who are unable to give their consent

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Hypoxia administration study group
Phase:
Study Start date:
February 13, 2025
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Centre Investigation Clinique CIC1402 - CHU Poitiers

    Poitiers,
    France

    Active - Recruiting

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