protocolSection identificationModule nctId: NCT06376240, orgStudyIdInfo id: NL85203.068.23, briefTitle: The Effect of Pyridoxamine Supplementation on Microvascular Function in Type 2 Diabetes, acronym: PYRAMID, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-21, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Maastricht University Medical Center, class: OTHER, collaborators name: Diabetes Fonds, descriptionModule briefSummary: Patients with type 2 diabetes have an increased risk of developing vascular complications. Microvascular dysfunction might be caused by the increased production of methylglyoxal under hyperglycaemic conditions. Methylglyoxal is a by-product of glycolysis and forms advanced glycation endproducts (AGEs) on proteins and DNA, thereby disrupting their function. Preventing methylglyoxal accumulation and AGEs formation may offer a therapeutic option for treating microvascular complications in diabetics. Pyridoxamine is a vitamin B6 vitamer that scavenges methylglyoxal and thereby inhibits the formation of AGEs. In this study, the researchers investigate whether pyridoxamine supplementation in type 2 diabetes improves microvascular function in the eye, kidney and skin, and reduces markers of endothelial dysfunction and glycation., conditionsModule conditions: Type 2 Diabetes, conditions: Microvascular Function, conditions: Retinopathy, Diabetic, conditions: Nephropathy, Diabetic, conditions: Neuropathy, Diabetic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Pyridoxamine 300mg per day, interventions name: Placebo 300mg placebo per day, outcomesModule primaryOutcomes measure: Central retinal artery equivalent of the eye, otherOutcomes measure: eGFR, otherOutcomes measure: Microvascular function in skin, otherOutcomes measure: Markers of endothelial function and glycation in blood plasma., otherOutcomes measure: Advanced glycation end products in skin, otherOutcomes measure: Advanced glycation end products in blood plasma and urine, otherOutcomes measure: Adipokines and inflammatory markers in blood plasma, otherOutcomes measure: Methylglyoxal, glyoxal and 3-deoxyglucose in blood plasma., otherOutcomes measure: Markers of dicarbonyl stress and oxidative stress in urine, otherOutcomes measure: Glucose metabolism, otherOutcomes measure: Liver fat, otherOutcomes measure: Systolic and diastolic blood pressure, otherOutcomes measure: Microvascular function eye, otherOutcomes measure: Urinary albumin, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Academic Hospital Maastricht, status: RECRUITING, city: Maastricht, zip: 6229 HX, country: Netherlands, contacts name: CTCM Clinical Trial Center Maastricht, role: CONTACT, phone: + 31 (0) 43 387 20 40, email: secretariaat.ctcm@mumc.nl, geoPoint lat: 50.84833, lon: 5.68889, hasResults: False