Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT02695251
Status:
COMPLETED
Last Update Posted:
2025-09-03
First Post:
2016-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AGE - Functional Reserve
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2016-02-26', 'studyFirstSubmitQcDate': '2016-02-29', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Renal Blood Flow', 'timeFrame': '120 minutes after meal', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'renal oxygen content', 'timeFrame': '120 minutes after meal', 'description': 'Differences in renal oxygen content will be assessed after either a high or low AGE meal with BOLD (Blood Oxygen Level Dependant) - MRI'}, {'measure': 'renal oxidative metabolism', 'timeFrame': '120 minutes after meal', 'description': 'Differences in renal oxidative metabolism will be assessed after either a high or low AGE meal with PET MRI using 11C labeled - Acetate'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Kidney Function Tests']}, 'referencesModule': {'references': [{'pmid': '29610272', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males subjects\n* age between 18 and 30 years old\n\nExclusion Criteria:\n\n* Kidney disease\n* Diabetes\n* Obesity\n* Hypertension\n* Non Steroidal Anti Inflammatory Drug treatment (NSAIDS)\n* MRI Contra indications\n* Myeloma\n* High basal Radiation exposure : more than 1 milliSievert (mSv) in the last 6 months'}, 'identificationModule': {'nctId': 'NCT02695251', 'acronym': 'AGE-FR', 'briefTitle': 'AGE - Functional Reserve', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': '69HCL15_0122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low AGE meal', 'description': 'Renal functional parameters are measured at baseline and after a low AGE (eggs) meal', 'interventionNames': ['Other: low AGE meal']}, {'type': 'EXPERIMENTAL', 'label': 'High AGE meal', 'description': 'Renal functional parameters are measured at baseline and after a high (mixed nuggets) AGE (eggs) meal', 'interventionNames': ['Other: High AGE meal']}], 'interventions': [{'name': 'low AGE meal', 'type': 'OTHER', 'description': 'Patients will receive a low AGE (eggs) meal', 'armGroupLabels': ['Low AGE meal']}, {'name': 'High AGE meal', 'type': 'OTHER', 'description': 'Patients will receive a high (mixed nuggets) AGE (eggs) meal', 'armGroupLabels': ['High AGE meal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69437', 'city': 'Lyon', 'country': 'France', 'facility': 'Service de Néphrologie - Hôpital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Laurent JUILLARD, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}