AGE - Functional Reserve

Kidney Function Tests Clinical Trial

— AGE-FR  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02695251
• Other study ID #: 69HCL15_0122
• Status: Completed
• Phase: N/A
• First received: February 26, 2016
• Last updated: August 2, 2017
• Start date: February 2016
• Est. completion date: July 2016

Study information

• Verified date: February 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Function Tests

Intervention

Other:
• low AGE meal
Patients will receive a low AGE (eggs) meal
• High AGE meal
Patients will receive a high (mixed nuggets) AGE (eggs) meal

Locations

Country	Name	City	State
France	Service de Néphrologie - Hôpital Edouard Herriot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	renal oxygen content	Differences in renal oxygen content will be assessed after either a high or low AGE meal with BOLD (Blood Oxygen Level Dependant) - MRI	120 minutes after meal
Secondary	renal oxidative metabolism	Differences in renal oxidative metabolism will be assessed after either a high or low AGE meal with PET MRI using 11C labeled - Acetate	120 minutes after meal