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NCT Number: NCT06846034

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Investigation Clinique CIC1402 - CHU Poitiers

Poitiers, France

Location status: Recruiting

Location contact

Christophe RAULT, MD PhD

SUB_INVESTIGATOR

Emilie RABOIS, MSc

CONTACT

[email protected]

+33(0)549444689

Pierre Jean SAULNIER, MD PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Hypoxia administration study group

Other

Acute 2-hour hypoxia (14.5%FiO2 corresponding to 3000m altitude)

Renal clairance study

Combination Product

Assessment of renal clearance by measuring Glomerular Filtration Rate (GFR) after two agents infusion:

  • Aminohippurate Sodium (or or para-aminohippuric acid [PAH]) Inj 20% Diagnostic agent used to measure effective renal plasma flow (ERPF)
  • Iohexol Inj 300 MG/ML Diagnostic agent used to measure glomerular filtration rate (GFR)

Primary outcomes

  1. Effective Renal Plasma Flow (ERPF)

    Time frame: 5 hours

    Measured by PAH clearance

  2. Glomerular Filtration Rate

    Time frame: 5 hours

    Measured by Iohexol Clearance

Secondary outcomes

  1. circulating and urinary mitochondrial metabolites

    Time frame: 8 days

    To investigate change of blood or urine metabolites : 2-ethyl 3-OH propionate, 3-hydroxy propionate, 3-hydroxy isovalerate, 3-methyl-crotonyl glycine, 3-hydroxy isobutyrate, Tiglyglycine, Aconitic acid, Citric acid, Glycolic acid, Homovanillic acid, Uracil, 3-methyl adipic acid.

  2. blood pressure

    Time frame: 5 hours

    mean arterial pressure

  3. heart rate

    Time frame: 5 hours

    heart rate

  4. Lake Louise Questionnaire

    Time frame: 5 hours

    The Lake Louise Scoring was developed to assess the symptoms of acute mountain sickness in adults. It consist of 4 questions, each rated on a likert-type scale with 0-3 response options. Lower scores men a better outcome.

  5. Oxygen saturation

    Time frame: 5 hours

    SpO2

Other outcomes

  1. Renal Oxygenation Availability

    Time frame: 60 minutes

    Blood oxygen level dependent (BOLD) MRI

  2. Cardiac Oxygenation Availability

    Time frame: 60 minutes

    Blood oxygen level dependent (BOLD) MRI

Study contacts

Contact information is provided by the study sponsor or research team.

Céline DELETAGE METREAU, PhD

CONTACT

[email protected]

Emilie RABOIS, MSc

CONTACT

[email protected]

+330549444686

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

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

Acronym: DIAKIPOX

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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