AGE - Functional Reserve

NCT02695251 | Completed

• 1 other identifier: 69HCL15_0122
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Function Tests

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• renal oxygen content

  120 minutes after meal

• renal oxidative metabolism

  120 minutes after meal

Study Arms (2)

Low AGE meal

EXPERIMENTAL

Renal functional parameters are measured at baseline and after a low AGE (eggs) meal

Other: low AGE meal

High AGE meal

EXPERIMENTAL

Renal functional parameters are measured at baseline and after a high (mixed nuggets) AGE (eggs) meal

Other: High AGE meal

Interventions

low AGE meal OTHER

Patients will receive a low AGE (eggs) meal

Low AGE meal

High AGE meal OTHER

Patients will receive a high (mixed nuggets) AGE (eggs) meal

High AGE meal

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de Néphrologie - Hôpital Edouard Herriot

Lyon, 69437, France

Location

Related Publications (1)

• Normand G, Lemoine S, Villien M, Le Bars D, Merida I, Irace Z, Troalen T, Costes N, Juillard L. AGE Content of a Protein Load Is Responsible for Renal Performances: A Pilot Study. Diabetes Care. 2018 Jun;41(6):1292-1294. doi: 10.2337/dc18-0131. Epub 2018 Apr 2.

  PMID: 29610272 BACKGROUND

Study Officials

• Laurent JUILLARD, MD, PhD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2016
• First Posted: March 1, 2016
• Study Start: February 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)