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OpenTrials
Completed

NCT Number: NCT02695251

AGE - Functional Reserve

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.

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Key information

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Service de Néphrologie - Hôpital Edouard Herriot

Lyon, 69437, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

low AGE meal

Other

Patients will receive a low AGE (eggs) meal

High AGE meal

Other

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

Primary outcomes

  1. Renal Blood Flow

    Time frame: 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 outcomes

  1. renal oxygen content

    Time frame: 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

  2. renal oxidative metabolism

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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.

Acronym: AGE-FR

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 1, 2016
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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