Trial reportEndocrinology, diabetes & metabolism2026
Effects of SGLT-2 Inhibitors on Plasma Concentrations and Renal Clearance of the Risk Marker Trimethylamine-N-Oxide in Patients With Type-2 Diabetes.
Trial report in Endocrinology, diabetes & metabolism, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02383238. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Randomized, Placebo Controlled, Crossover Clinical Study to Analyse the Effect of Dapagliflozin on Microvascular and Macrovascular Circulation and Total Body Sodium Content
Randomized, Double-blind, Placebo Controlled, Crossover Clinical Study to Analyse the Effect of Empagliflozin on Macrovascular and Microvascular Circulation and on Endothelium Function
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Authors and funding
7 authors.
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Abstract
backgroundSodium-glucose cotransporter-2 (SGLT-2) inhibitors have become a key drug class in the treatment of Type 2 diabetes (T2D) due to their effectiveness in blood sugar control, but also for many other clinical indications because of beneficial effects on cardiovascular diseases and mortality. Therefore, the findings of a secondary analysis of the recent EMMY trial, in which acute myocardial infarction patients treated with empagliflozin had higher trimethylamine-N-oxide (TMAO) serum levels compared to placebo, were unexpected, as high TMAO concentrations in blood have previously been linked to adverse cardiovascular and mortality outcomes. In light of this, the aim of our study was to explore the effects of the SGLT-2 inhibitors empagliflozin and dapagliflozin on plasma concentrations and renal clearance (Cl
methodsPlasma and 24-h urine samples from two prospective, randomised, placebo-controlled, double-blind, cross-over trials with T2D patients (empagliflozin N = 69, NCT02471963; dapagliflozin N = 54, NCT02383238), taken at baseline and after each treatment with either SGLT-2 inhibitor or placebo, were measured for TMAO via LC-MS/MS.
resultsAfter treatment with an SGLT-2 inhibitor, in the total of 123 patients, TMAO plasma levels were 11.5% higher compared to placebo (p = 0.006) and Cl
conclusionTreatment with an SGLT-2 inhibitor was associated with a modest increase in plasma concentration of TMAO. Together with data from a previous trial, the present findings suggest a possible class effect of SGLT-2 inhibitors. Whether this effect impacts the overall clinical benefits of SGLT-2 inhibitors needs to be subject to further investigations.
trial registrationhttp://www. CLINICALTRIALS: gov: NCT02471963 (registered 15th June 2015, retrospectively registered) and NCT02383238.
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