Effect of Acute Hypoxia on Renal Hemodynamic in Healthy Volunteers, Patients With Diabetes and Patients With Diabetes and Kidney Disease
DIAKIPOX
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes
Started Feb 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2025
CompletedStudy Start
First participant enrolled
February 13, 2025
CompletedFirst Posted
Study publicly available on registry
February 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
April 9, 2025
April 1, 2025
1.5 years
February 13, 2025
April 7, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Effective Renal Plasma Flow (ERPF)
Measured by PAH clearance
5 hours
Glomerular Filtration Rate
Measured by Iohexol Clearance
5 hours
Secondary Outcomes (5)
circulating and urinary mitochondrial metabolites
8 days
blood pressure
5 hours
heart rate
5 hours
Lake Louise Questionnaire
5 hours
Oxygen saturation
5 hours
Other Outcomes (2)
Renal Oxygenation Availability
60 minutes
Cardiac Oxygenation Availability
60 minutes
Study Arms (1)
acute hypoxia
OTHERThe participant will be exposed to 2 sequences : a 3-hour normoxia period and then a 2-hour hypoxia (FiO2=14.26% corresponding to 3000m altitude) period.
Interventions
Acute 2-hour hypoxia (14.5%FiO2 corresponding to 3000m altitude)
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)
Eligibility Criteria
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
- No proliferative diabetic retinopathy
- +6 more criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Investigation Clinique CIC1402 - CHU Poitiers
Poitiers, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre Jean SAULNIER, MD PhD
CHU Poitiers
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2025
First Posted
February 25, 2025
Study Start
February 13, 2025
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
April 9, 2025
Record last verified: 2025-04