AGE - Functional Reserve (AGE-FR)

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Kidney Function Tests

Treatments

Other: High AGE meal
Other: low AGE meal

Study type

Interventional

Funder types

Other

Identifiers

NCT02695251
69HCL15_0122

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

Male

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

10 participants in 2 patient groups

Low AGE meal
Experimental group
Description:
Renal functional parameters are measured at baseline and after a low AGE (eggs) meal
Treatment:
Other: low AGE meal
High AGE meal
Experimental group
Description:
Renal functional parameters are measured at baseline and after a high (mixed nuggets) AGE (eggs) meal
Treatment:
Other: High AGE meal

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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