DiabetesDIAKIPOXNCT06846034
Effect of Acute Hypoxia on Renal Hemodynamic in Healthy Volunteers, Patients With Diabetes and Patients With Diabetes and Kidney Disease
A study testing Hypoxia administration study group and Renal clairance study in people with Diabetes and Diabetic Kidney Disease, run by Poitiers University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Diabetic Kidney Disease, Hypoxia
- What is being tested?
- Hypoxia administration study group and Renal clairance study
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Céline DELETAGE METREAU, PhD contact
France1 site, 1 recruiting
- Recruiting
Centre Investigation Clinique CIC1402 - CHU Poitiers
Poitiers
Emilie RABOIS, MSc, +33(0)549444689, emilie.rabois@chu-poitiers.fr
Pierre Jean SAULNIER, MD PhD
About this study
Official title: Effect of Acute Hypoxia on Renal Hemodynamic in Healthy Volunteers, Patients With Diabetes and Patients With Diabetes and Kidney Disease : Pilot Study.
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.
Read more
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.
- Being tested
- Hypoxia administration study group, Renal clairance study
- Medical subject headings
- Diabetes Mellitus, Diabetic Nephropathies, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoxia administration study groupOther
Acute 2-hour hypoxia (14.5%FiO2 corresponding to 3000m altitude)
Renal clairance studyCombination 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)
| Study group | Role | What they receive |
|---|---|---|
| acute hypoxia | Other | The 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. Receives: Other: Hypoxia administration study group; Combination Product: Renal clairance study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective Renal Plasma Flow (ERPF)
Measured by PAH clearance
Measured: 5 hours
Glomerular Filtration Rate
Measured by Iohexol Clearance
Measured: 5 hours
Secondary outcomes (5)
circulating and urinary mitochondrial metabolites
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.
Measured: 8 days
blood pressure
mean arterial pressure
Measured: 5 hours
heart rate
heart rate
Measured: 5 hours
Lake Louise Questionnaire
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.
Measured: 5 hours
Oxygen saturation
SpO2
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start13 Feb 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- It is a descriptive, prospective, open label, single centre, pilot study. This research aim to better understand the effect of hypoxia on intrarenal hemodynamic parameters of 3 groups : Group 1: Healthy volunteers Group 2: Patient with Type 2 Diabetes (DT2) without Diabetic Kidney Disease (DKD) Group 3: Patient with T2D and DKD
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Jean SAULNIER, MD PhD, Principal investigator, CHU Poitiers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846034
- Sponsor's protocol ID
- DIAKIPOX
- Acronym
- DIAKIPOX
- Status last verified
- Apr 2025
- First submitted
- 13 Feb 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acute Hypoxia on Renal Hemodynamic in Healthy Volunteers, Patients With Diabetes and Patients With Diabetes and Kidney Disease : Pilot Study.
- ClinicalTrials.gov ID
- NCT06846034
- Acronym / sponsor ID
- DIAKIPOX / DIAKIPOX
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- It is a descriptive, prospective, open label, single centre, pilot study. This research aim to better understand the effect of hypoxia on intrarenal hemodynamic parameters of 3 groups : Group 1: Healthy volunteers Group 2: Patient with Type 2 Diabetes (DT2) without Diabetic Kidney Disease (DKD) Group 3: Patient with T2D and DKD
| Arm | Type | Receives |
|---|---|---|
| acute hypoxia | Other | Other: Hypoxia administration study group, Combination Product: Renal clairance studyThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- No history of respiratory diseases
- Affiliated person or beneficiary of the French social security scheme.
- signed informed consent
- [18; 40] years old
- No history of diabetes
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypoxia administration study groupAcute 2-hour hypoxia (14.5%FiO2 corresponding to 3000m altitude) | Other | acute hypoxia |
| Renal clairance studyAssessment 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) | Combination product | acute hypoxia |
Primary outcome
Effective Renal Plasma Flow (ERPF)
Time frame: 5 hours
Measured by PAH clearance
Glomerular Filtration Rate
Time frame: 5 hours
Measured by Iohexol Clearance
5 secondary outcomes
circulating and urinary mitochondrial metabolites
Time frame: 8 days
blood pressure
Time frame: 5 hours
heart rate
Time frame: 5 hours
Lake Louise Questionnaire
Time frame: 5 hours
Oxygen saturation
Time frame: 5 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Céline DELETAGE METREAU, PhD contact
Pierre Jean SAULNIER, MD PhD principal investigator
CHU Poitiers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoxia administration study group and Renal clairance study in people with Diabetes and Diabetic Kidney Disease, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilie RABOIS, MSc (+330549444686, emilie.rabois@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective Renal Plasma Flow (ERPF) (time frame: 5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.