NCT06846034Recruiting
Effect of Acute Hypoxia on Renal Hemodynamic in Healthy Volunteers, Patients With Diabetes and Patients With Diabetes and Kidney Disease
Effect of Acute Hypoxia on Renal Hemodynamic in Healthy Volunteers, Patients With Diabetes and Patients With Diabetes and Kidney Disease : Pilot Study.
Source: ClinicalTrials.gov · Last updated 9 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 13 Feb 2025
- Start date
- 13 Feb 2025
- Primary completion date
- Sept 2026
- Lead sponsor
- Poitiers University Hospital
- Diseases
- Chronic kidney disease
- NCT number
- NCT06846034
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 13 Feb 2025 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Consumption of SGLT2 inhibitors
- Concurrent participation in another clinical research study
Other illness
- 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)
- History of severe mountain sickness (dizziness, headache, nausea/vomiting and incapaciting fatigue)
- Persons under psychiatric care who are unable to give their consent
Age
- Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception
Other
- For all participants:
- Active smoking
- Contraindication to any of the agent (PAH, or iohexol or gadolinium) used in the study.
- Resting oxygen saturation \<95% at baseline
- Persons benefiting from enhanced protection under french national law
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Investigation Clinique CIC1402 - CHU Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.