PMID- 37093196
OWN - NLM
STAT- MEDLINE
DCOM- 20230707
LR  - 20230718
IS  - 1557-8593 (Electronic)
IS  - 1520-9156 (Linking)
VI  - 25
IP  - 7
DP  - 2023 Jul
TI  - 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.
PG  - 467-475
LID - 10.1089/dia.2023.0036 [doi]
AB  - 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.
FAU - Ferreira, Antonio
AU  - Ferreira A
AD  - Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, 
      Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
FAU - Schonenberger, Katja A
AU  - Schonenberger KA
AUID- ORCID: 0000-0002-2122-4746
AD  - Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, 
      Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
AD  - Division of Clinical Pharmacy and Epidemiology, Department of Pharmaceutical 
      Sciences, University of Basel, Basel, Switzerland.
FAU - Potoczna, Natascha
AU  - Potoczna N
AD  - Stoffwechselpraxis, Stoffwechselzentrum Hirslanden Clinic St. Anna, Lucerne, 
      Switzerland.
FAU - Vogt, Andreas
AU  - Vogt A
AD  - Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University 
      Hospital, University of Bern, Bern, Switzerland.
FAU - Gerber, Philipp A
AU  - Gerber PA
AD  - Department of Endocrinology, Diabetology and Clinical Nutrition, University 
      Hospital Zurich (USZ) and University of Zurich (UZH), Zurich, Switzerland.
FAU - Zehetner, Jorg
AU  - Zehetner J
AD  - Department of Visceral Surgery, Hirslanden Clinic Beau-Site, Bern, Switzerland.
FAU - Giachino, Daniel
AU  - Giachino D
AD  - Department of Visceral Surgery, Lindenhofspital, Bern, Switzerland.
FAU - Nett, Philipp
AU  - Nett P
AD  - Department of Visceral Surgery and Medicine, Inselspital, Bern University 
      Hospital, University of Bern, Bern, Switzerland.
FAU - Gawinecka, Joanna
AU  - Gawinecka J
AD  - Department of Clinical Chemistry, University Hospital Zurich, University of 
      Zurich, Zurich, Switzerland.
FAU - Cossu, Luca
AU  - Cossu L
AUID- ORCID: 0000-0002-8804-0722
AD  - Department of Information Engineering, University of Padova, Padova, Italy.
FAU - Fuster, Daniel G
AU  - Fuster DG
AD  - Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, 
      University of Bern, Bern, Switzerland.
FAU - Dalla Man, Chiara
AU  - Dalla Man C
AD  - Department of Information Engineering, University of Padova, Padova, Italy.
FAU - Facchinetti, Andrea
AU  - Facchinetti A
AD  - Department of Information Engineering, University of Padova, Padova, Italy.
FAU - Melmer, Andreas
AU  - Melmer A
AD  - Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, 
      Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
FAU - Nakas, Christos T
AU  - Nakas CT
AD  - Laboratory of Biometry, University of Thessaly, Nea Ionia/Volos, Magnesia, 
      Greece.
AD  - Department of Clinical Chemistry, Inselspital, Bern University Hospital, 
      University of Bern, Bern, Switzerland.
FAU - Hepprich, Matthias
AU  - Hepprich M
AD  - Department of Endocrinology, Diabetes and Metabolism, University Hospital Basel, 
      Basel, Switzerland.
FAU - Donath, Marc Y
AU  - Donath MY
AD  - Department of Endocrinology, Diabetes and Metabolism, University Hospital Basel, 
      Basel, Switzerland.
FAU - Herzig, David
AU  - Herzig D
AD  - Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, 
      Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
FAU - Bally, Lia
AU  - Bally L
AUID- ORCID: 0000-0003-1993-7672
AD  - Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, 
      Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
LA  - eng
SI  - ClinicalTrials.gov/NCT05057819
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20230605
PL  - United States
TA  - Diabetes Technol Ther
JT  - Diabetes technology & therapeutics
JID - 100889084
RN  - HDC1R2M35U (empagliflozin)
RN  - 0 (Blood Glucose)
RN  - IY9XDZ35W2 (Glucose)
SB  - IM
MH  - Adult
MH  - Humans
MH  - *Gastric Bypass/adverse effects
MH  - Blood Glucose
MH  - Blood Glucose Self-Monitoring
MH  - Cross-Over Studies
MH  - *Hypoglycemia/drug therapy/etiology/prevention & control
MH  - Glucose
MH  - Double-Blind Method
OTO - NOTNLM
OT  - Bariatric surgery
OT  - Glucose variability
OT  - Hypoglycemia
OT  - Postprandial glucose metabolism
OT  - Roux-en-Y gastric bypass
OT  - SGLT2 inhibition
EDAT- 2023/04/24 12:42
MHDA- 2023/07/07 06:42
CRDT- 2023/04/24 11:03
PHST- 2023/07/07 06:42 [medline]
PHST- 2023/04/24 12:42 [pubmed]
PHST- 2023/04/24 11:03 [entrez]
AID - 10.1089/dia.2023.0036 [doi]
PST - ppublish
SO  - Diabetes Technol Ther. 2023 Jul;25(7):467-475. doi: 10.1089/dia.2023.0036. Epub 
      2023 Jun 5.