protocolSection identificationModule nctId: NCT06291155, orgStudyIdInfo id: HUM00222335, briefTitle: Renal Mechanism of SGLT2 Inhibition, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2028-06-30, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University of Michigan, class: OTHER, collaborators name: University of Colorado, Denver, collaborators name: Renal Pre-Competitive Consortium (RPC3), descriptionModule briefSummary: The goal of this open-label, non-randomized clinical trial is to determine what effects, if any, an FDA-approved drug class known as SGLT2 inhibitors (Canagliflozin or INVOKANA) has any protective effects on kidney function in Type 2 diabetes. We are looking for participants 18-80 years of age, who have had a clinical diagnosis of Type 2 diabetes for ≥ 3 years.Participants will be asked to sign a consent and complete a screening visit prior to study entry including the following procedures for this study:Consent and Screening:* Laboratory tests to determine baseline health* Ultrasound to measure kidney size and ensure presence of 2 functioning kidneysMonth 0:* Study entry kidney MRI (day 0)* Study entry kidney biopsy (within 30 days of MRI)* Study entry visit for dispensing 100 mg/daily Canagliflozin medication 3 month supplyMonth 3:* Study visit to dispense remaining 3 months of 100 mg/daily Canagliflozin medication* Review of systemsMonth 6:* Follow-up kidney MRI* Follow-up kidney biopsyStudy participants will also be requested to provide blood and urine samples for biobanking purposes. They will also be provided the opportunity to provide a stool sample at two time points, as well as the option to participate in a related study collecting samples to create induced Pluripotent Stem Cells (iPSCs).Participants will be compensated for their time and loss of work time, additionally, a nominal additional compensation for optional stool and iPSC samples., conditionsModule conditions: Type 2 Diabetes, conditions: Diabetic Kidney Disease, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is an open-label, non-randomized mechanistic trial of an FDA-approved drug, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: SGLT2 inhibitor, outcomesModule primaryOutcomes measure: Glomerular basement membrane (GBM) width and mesangial expansion, secondaryOutcomes measure: Kidney Transcript Changes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Michigan, status: RECRUITING, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Chrysta C Lienczewski, BS, role: CONTACT, phone: 734-615-5021, email: boridley@umich.edu, contacts name: Markus Bitzer, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, hasResults: False