AGE - Functional Reserve

NCT ID: NCT02695251

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Low AGE meal

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

Group Type: EXPERIMENTAL

low AGE meal

Intervention Type: OTHER

Patients will receive a low AGE (eggs) meal

High AGE meal

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

Group Type: EXPERIMENTAL

High AGE meal

Intervention Type: OTHER

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

Interventions

low AGE meal

Patients will receive a low AGE (eggs) meal

Intervention Type: OTHER

High AGE meal

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent JUILLARD, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Service de Néphrologie - Hôpital Edouard Herriot

Lyon, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 29610272 (View on PubMed)

Other Identifiers

69HCL15_0122

Identifier Type: -

Identifier Source: org_study_id