Centre Investigation Clinique CIC1402 - CHU Poitiers
Poitiers, France
Location status: Recruiting
Location contact
Christophe RAULT, MD PhD
SUB_INVESTIGATOR
Emilie RABOIS, MSc
CONTACT
Pierre Jean SAULNIER, MD PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06846034
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Poitiers, France
Location status: Recruiting
Christophe RAULT, MD PhD
SUB_INVESTIGATOR
Emilie RABOIS, MSc
CONTACT
Pierre Jean SAULNIER, MD PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For all participant :
Group 1 ( For healthy volunteers):
For all the patients with T2D (group 2 and 3):
Group 2 - For patients with T2D and no DKD:
Group 3 - For patients with DKD:
Exclusion criteria
For all participants:
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:
Time frame: 5 hours
Measured by PAH clearance
Time frame: 5 hours
Measured by Iohexol Clearance
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.
Time frame: 5 hours
mean arterial pressure
Time frame: 5 hours
heart rate
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.
Time frame: 5 hours
SpO2
Time frame: 60 minutes
Blood oxygen level dependent (BOLD) MRI
Time frame: 60 minutes
Blood oxygen level dependent (BOLD) MRI
Contact information is provided by the study sponsor or research team.
Céline DELETAGE METREAU, PhD
CONTACT
Emilie RABOIS, MSc
CONTACT
Poitiers University Hospital
Other
Effect of Acute Hypoxia on Renal Hemodynamic in Healthy Volunteers, Patients With Diabetes and Patients With Diabetes and Kidney Disease : Pilot Study.
Acronym: DIAKIPOX
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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