Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypoxia administration study group | Other | Acute 2-hour hypoxia (14.5%FiO2 corresponding to 3000m altitude) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effective Renal Plasma Flow (ERPF) | Measured by PAH clearance | 5 hours |
| Glomerular Filtration Rate | Measured by Iohexol Clearance | 5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Renal Oxygenation Availability | Blood oxygen level dependent (BOLD) MRI | 60 minutes |
| Cardiac Oxygenation Availability | Blood oxygen level dependent (BOLD) MRI |
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:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emilie RABOIS, MSc | Contact | +330549444686 | emilie.rabois@chu-poitiers.fr | |
| Céline DELETAGE METREAU, PhD | Contact | Celine.DELETAGE-METREAU@chu-poitiers.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pierre Jean SAULNIER, MD PhD | CHU Poitiers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Investigation Clinique CIC1402 - CHU Poitiers | Recruiting | Poitiers | France |
Not provided
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
Not provided
Not provided
Not provided
Not provided
| Renal clairance study | Combination Product | Assessment of renal clearance by measuring Glomerular Filtration Rate (GFR) after two agents infusion:
|
|
| blood pressure |
mean arterial pressure |
| 5 hours |
| heart rate | heart rate | 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. | 5 hours |
| Oxygen saturation | SpO2 | 5 hours |
| 60 minutes |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003928 | Diabetic Nephropathies |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided