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Clinical Trial Details

Trial ID: L2478
Source ID: NCT04535960
Associated Drug: Empagliflozin 25 Mg + Liraglutide 1.8 Mg
Title: Incretin and Treatment With Inhibition of Sodium-glucose Cotransporter-2 Combination Insights Into Mechanisms Implicated in Congestive Heart Failure: "NATRIURETIC" Trial
Acronym: NATRIURETIC
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Empagliflozin 25 MG + Liraglutide 1.8 MG|DRUG: Liraglutide 1.8 MG + Empagliflozin 25 MG
Outcome Measures: Primary: Proximal tubular natriuresis, Measured by fractional excretion of sodium, up to 12 weeks | Secondary: Glomerular Filtration Rate, GFR, Glomerular Filtration Rate (GFR, based on plasma iohexol clearance) will be measured at 2 time points: monotherapy (6 weeks) and combination therapy (12 weeks)|Systolic blood pressure, SBP, Systolic blood pressure (SBP) will be measured at 2 time points: monotherapy (6 weeks) and combination therapy (12 weeks)|Body weight, Kilograms, Body weight will be measured at 2 time points: monotherapy (6 weeks) and combination therapy (12 weeks)|Arterial stiffness, Measured using a Sphygmocor device, Arterial stiffness will be measured at 2 time points: monotherapy (6 weeks) and combination therapy (12 weeks)|Systemic vascular resistance, Measured using non-invasive cardiac output monitor (NICOM), Systemic vascular resistance will be measured at 2 time points: monotherapy (6 weeks) and combination therapy (12 weeks)|Urinary concentration of the renin-angiotensin aldosterone system (RAAS) markers, Measured using ELISA, Outcome will be measured at 2 time points: monotherapy (6 weeks) and combination therapy (12 weeks)|Urinary EGF,FGF2,Eotaxin,TGFa,G-CSF,Flt-3L,GM-CSF,Fractalkine,IFNa2,IFNy,GRO,IL10,MCP-3,IL-12P40,MDC,IL-12P70,PDGF-AA,IL-13,PDGF-BB,IL-15,sCD40L,IL-17A,IL-1RA,IL1a,IL9,IL1B,IL2,IL3,IL4,IL5,IL6,IL7,IL8,IL10,MCP-1,MIP-1a,MIP-1B,RANTES,TNFalpha,TNFB,VEGF, 41-plex chemo/chemokine profile assay: urinary, Outcome will be measured at 2 time points: monotherapy (6 weeks) and combination therapy (12 weeks)
Sponsor/Collaborators: Sponsor: University Health Network, Toronto
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 36
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-01-24
Completion Date: 2023-10
Results First Posted:
Last Update Posted: 2023-05-17
Locations: Renal Physiology Laboratory, Toronto, Ontario, Canada
URL: https://clinicaltrials.gov/show/NCT04535960