التفاصيل البيبلوغرافية
| العنوان: |
Randomized, Double-Blind, Placebo-Controlled Crossover Trial of Once Daily Empagliflozin 25 mg for the Treatment of Postprandial Hypoglycemia After Roux-en-Y Gastric Bypass. |
| المؤلفون: |
Ferreira, Antonio1 (AUTHOR), Schönenberger, Katja A.1,2 (AUTHOR), Potoczna, Natascha3 (AUTHOR), Vogt, Andreas4 (AUTHOR), Gerber, Philipp A.5 (AUTHOR), Zehetner, Jörg6 (AUTHOR), Giachino, Daniel7 (AUTHOR), Nett, Philipp8 (AUTHOR), Gawinecka, Joanna9 (AUTHOR), Cossu, Luca10 (AUTHOR), Fuster, Daniel G.11 (AUTHOR), Dalla Man, Chiara10 (AUTHOR), Facchinetti, Andrea10 (AUTHOR), Melmer, Andreas1 (AUTHOR), Nakas, Christos T.12,13 (AUTHOR), Hepprich, Matthias14 (AUTHOR), Donath, Marc Y.14 (AUTHOR), Herzig, David1 (AUTHOR), Bally, Lia1 (AUTHOR) lia.bally@insel.ch |
| المصدر: |
Diabetes Technology & Therapeutics. Jul2023, Vol. 25 Issue 7, p467-475. 9p. |
| مصطلحات موضوعية: |
*GASTRIC bypass, *CROSSOVER trials, *HYPOGLYCEMIA, *BLOOD sugar, *EMPAGLIFLOZIN |
| مستخلص: |
Aims: To investigate the effect of empagliflozin on glucose dynamics in individuals suffering from postbariatric hypoglycemia (PBH) after Roux-en-Y gastric bypass (RYGB). Methods: Twenty-two adults with PBH after RYGB were randomized to empagliflozin 25 mg or placebo once daily over 20 days in a randomized, double-blind, placebo-controlled, crossover trial. The primary efficacy outcome was the amplitude of plasma glucose excursion (peak to nadir) during a mixed-meal tolerance test (MMTT). Outcomes of the outpatient period were assessed using continuous glucose monitoring (CGM) and an event-tracking app. Results: The amplitude of glucose excursion during the MMTT was 8.1 ± 2.4 mmol/L with empagliflozin versus 8.1 ± 2.6 mmol/L with placebo (mean ± standard deviation, P = 0.807). CGM-based mean amplitude of glucose excursion during the 20-day period was lower with empagliflozin than placebo (4.8 ± 1.3 vs. 5.2 ± 1.6. P = 0.028). Empagliflozin reduced the time spent with CGM values >10.0 mmol/L (3.8 ± 3.5% vs. 4.7 ± 3.8%, P = 0.009), but not the time spent with CGM values <3.0 mmol/L (1.7 ± 1.6% vs. 1.5 ± 1.5%, P = 0.457). No significant difference was observed in the quantity and quality of recorded symptoms. Eleven adverse events occurred with empagliflozin (three drug-related) and six with placebo. Conclusions: Empagliflozin 25 mg reduces glucose excursions but not hypoglycemia in individuals with PBH. Clinical Trial Registration: Clinicaltrials.gov: NCT05057819 [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
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