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Clinical Trial Summary

This randomized trial is to test whether a treatment with empagliflozin is superior to placebo in patients with postprandial hypoglycemia after bariatric surgery, that is if it improves health related quality of life (mentally or physically) or reduces the risk of hypoglycemic events.


Clinical Trial Description

Postprandial hypoglycemia is a debilitating medical complication after bariatric surgery for which no approved pharmacological treatment exists. The prevalence of hypoglycemia in bariatric patients ranges from 0.5 % severe episodes up to 56 % and its symptoms range from asymptomatic to deleterious. This hypoglycemic condition is characterized by a rapid increase of plasma glucose after carbohydrate ingestion followed by an exaggerated hyperinsulinemic response. Hypoglycemia itself may lead to increased hunger, carbohydrate ingestion and following weight regain. In a placebo-controlled, randomized, double-blind, crossover study, the SGLT2-inhibitor empagliflozin statistically significantly reduced the number of symptomatic hypoglycemia (2 vs. 7 symptomatic hypoglycemic episodes; p=0.013) compared to placebo after a mixed meal test in 12 patients after Roux-en-Y gastric bypass. Empagliflozin reduced the postprandial rise in glycemia and decreased subsequent insulin secretion, underlining the postulated mechanism of action. This randomized trial is to test whether a treatment with empagliflozin is superior to placebo in patients with postprandial hypoglycemia after bariatric surgery, that is if it improves health related quality of life (mentally or physically) or reduces the risk of hypoglycemic events. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05036317
Study type Interventional
Source University Hospital, Basel, Switzerland
Contact Marc Y Donath, Prof. Dr. med.
Phone +41 61 265 25 25
Email [email protected]
Status Recruiting
Phase Phase 3
Start date October 2021
Completion date October 2023

See also
  Status Clinical Trial Phase
Completed NCT03984370 - Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric Bypass Phase 2
Completed NCT03200782 - Postprandial Hypoglycemia in Patients After Bariatric Surgery With Empagliflozin and Anakinra - The Hypo-BEAR-Study N/A
Recruiting NCT04836273 - Treatment of Post-bariatric Hypoglycaemia Phase 2
Completed NCT04330196 - Effect of Postprandial Hyperinsulinaemic Hypoglycaemia on Driving Performance. N/A
Recruiting NCT04720859 - Canagliflozin in Postprandial Hyperinsulinemic Hypoglycemia (CANA-PHH-RYGB) N/A
Completed NCT01162499 - Role of Glucagon-Like Peptide-1 in Postprandial Hypoglycemia N/A