No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
30 (estimated)
Sponsor
Poitiers University Hospital · Other
Who this trial is looking for
This trial is looking for healthy volunteers and patients with diabetes to study how low oxygen levels affect kidney health. Participants will undergo tests to measure kidney function under these conditions.
Are You a Good Fit for This Trial?
Must not be takingSGLT2 inhibitors
Rules you outType 1 diabetesHeart failureStroke
You may be able to join if
I am between 18 and 40 years old.
I do not have a history of diabetes.
I have signed informed consent.
I have no respiratory diseases.
I have a BMI between 18.5 and 29.9.
I have normal kidney function (eGFR > 60 ml/min).
I have normal to mildly increased albumin levels.
You may not be able to join if
I am an active smoker.
I have had a heart attack in the past 6 months.
I do not have stable hypertension.
I have resting oxygen saturation below 95%.
I have severe mountain sickness.
I am pregnant or breastfeeding.
I cannot provide consent due to psychiatric care.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 p…
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 Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
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 mon…
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 to inclusion
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 Criteria:
For all participants:
1. Active smoking
2. Contraindication to any of the agent (PAH, or iohexol or gadolinium) used in the study.
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 or transient ischemic neurologic disorder
6. Severe unstable hypertension (≥180 mmHg systolic or ≥110 mmHg diastolic blood pressure)
7. Resting oxygen saturation \<95% at baseline
8. 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.
9. History of severe mountain sickness (dizziness, headache, nausea/vomiting and incapaciting 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 effective contraception
13. Persons benefiting from enhanced protection under french national law
14. Persons under psychiatric care who are unable to give their consent
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.