AGE - Functional Reserve

Not Applicable

Completed

• Conditions: Kidney Function Tests
• Interventions: Other: High AGE meal; Other: low AGE meal

• Registration Number: NCT02695251
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2016-02
• Study Start: 2016-02
• Study First Submitted: 2016-02-26
• Study First Submitted QC: 2016-02-29
• Study First Posted: 2016-03-01
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2017-08-02
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

• Healthy males subjects
• age between 18 and 30 years old

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High AGE meal	High AGE meal	Renal functional parameters are measured at baseline and after a high (mixed nuggets) AGE (eggs) meal
Low AGE meal	low AGE meal	Renal functional parameters are measured at baseline and after a low AGE (eggs) meal

Primary Outcome Measures

Name	Time	Method
Renal Blood Flow	120 minutes after meal	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Service de Néphrologie - Hôpital Edouard Herriot; 🇫🇷 Lyon, France