AGE - Functional Reserve

Study Overview
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Brief Summary
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Renal functional reserve is defined as the glomerular hyper filtration induced by a protein load. Renal blood flow and Glomerular Filtration Rate (GFR) increase in response to a protein load. Renal functional reserve loss is associated with a persistent hyper filtration state, seen in first stages of diabetic nephropathy, leading to progression of Chronic Kidney Disease (CKD). This observation has lead to larger clinical studies that demonstrated the positive effects of protein restriction on kidney function, and allowed the scientific community to recommend low proteins diet (less than 0.8 g / kg/ day) to prevent CKD progression. Nevertheless, the precise mechanisms responsible for kidney hemodynamic and metabolic changes induced by a protein load, are debated. Uribarri et al have suggested that renal hemodynamic changes induced by a protein load are mainly due to the Advanced Glycation End Products (AGEs) content. Indeed, initial studies experimental conditions leading to the demonstration of renal functional reserve (amino acid or protein perfusion or cooked meat), were in fact responsible for an AGEs load, based on recent published data. The aim of this study is to determine whether AGEs alone or proteins in general are responsible for the mobilization of renal functional reserve, leading to the progression of CKD.

Official Title
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Renal Hemodynamic, Functional and Metabolic Changes After AGEs (Advanced Glycation End Products) Load by Positron Emission Tomography (PET) and Blood Oxygen Level-Dependent (BOLD) - MRI. The AGE- Functional Reserve Study.

Conditions
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Kidney Function Tests

Intervention / Treatment
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* Other: low AGE meal
* Other: High AGE meal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males subjects age between 18 and 30 years old Exclusion Criteria: Kidney disease Diabetes Obesity Hypertension Non Steroidal Anti Inflammatory Drug treatment (NSAIDS) MRI Contra indications Myeloma High basal Radiation exposure : more than 1 milliSievert (mSv) in the last 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low AGE meal<br>Renal functional parameters are measured at baseline and after a low AGE (eggs) meal | Other: low AGE meal<br>* Patients will receive a low AGE (eggs) meal<br>|
| Experimental: High AGE meal<br>Renal functional parameters are measured at baseline and after a high (mixed nuggets) AGE (eggs) meal | Other: High AGE meal<br>* Patients will receive a high (mixed nuggets) AGE (eggs) meal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal Blood Flow | Differences in Renal blood flow will be assessed 120 minutes after 2 different meals, either high AGE (mixed nuggets) or low AGE meal (mixed eggs), with PET- MRI using 150 labeled water. | 120 minutes after meal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal oxygen content | Differences in renal oxygen content will be assessed after either a high or low AGE meal with BOLD (Blood Oxygen Level Dependant) - MRI | 120 minutes after meal | 
| renal oxidative metabolism | Differences in renal oxidative metabolism will be assessed after either a high or low AGE meal with PET MRI using 11C labeled - Acetate | 120 minutes after meal |