Clinical Trials Logo

Clinical Trial Summary

Bariatric surgery is an effective anti-obesity treatment providing durable weight loss and profound beneficial effects on glucose metabolism. However, bariatric surgery also comes with an increased risk for a late metabolic complication known as postbariatric hypoglycaemia (PBH). The condition presents with hypoglycaemic episodes 1-3 hours after meals and develops one to several years after bariatric surgery, mainly gastric bypass. PBH affects approximately 30% of patients without preexisting diabetes. For a subset of patients, hypoglycaemia-associated impairment of daily living and social functioning are commonly observed. The underlying mechanisms of PBH are multifactorial. It is considered that inadequately high insulin secretion caused by both accelerated glucose absorption from the gut and increased insulinotropic hormones such as GLP-1 are important pathophysiologic mechanisms. Empagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor reduces glucose exposure by increasing urinary glucose excretion. In a pilot study, a single dose of 10mg of empagliflozin taken before a mixed meal reduced the risk of PBH by 74%. Both, postprandial glucose and insulin exposure were significantly lower with empagliflozin vs. placebo, which makes Empagliflozin a potential treatment for PBH. In this study, treatment naïve patients will be randomized to receive either oral empagliflozin 25 mg daily in the morning for 20 days, followed by 2-6 weeks wash out and 20 days placebo once daily in the morning, or the reverse sequence. Urine and blood analysis will be performed as detailed in the protocol.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05057819
Study type Interventional
Source University Hospital Inselspital, Berne
Contact Lia Bally, MD/PhD
Phone +41 (0)31 632 36 77
Email [email protected]
Status Not yet recruiting
Phase Phase 4
Start date November 1, 2021
Completion date February 28, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04028193 - Fat Supplementation on Dumping Syndrome Associated Symptoms N/A
Recruiting NCT00543179 - Treatment of the Dumping Syndrome With Lanreotide Autogel® Phase 4
Not yet recruiting NCT04522193 - Dumping Syndrome and Esophageal Atresia N/A
Completed NCT02891330 - Impact of an Educational Personalized Clinical Support Device Preventive and a Referent Nurse in Surgery for Obesity N/A
Completed NCT02525705 - Dumping Syndrome After Operation of Esophageal Atresia Type III N/A
Active, not recruiting NCT01794793 - Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies Phase 4
Completed NCT03734627 - Gastrointestinal Nutrient Transit and Enteroendocrine Function After Upper Gastrointestinal Surgery
Terminated NCT02836353 - Metabolic Consequences of Gastrointestinal Surgery N/A
Completed NCT02971631 - Gastrectomy, Eating Behaviour and GLP-1 N/A
Recruiting NCT01923649 - SOMATULINE Autogel 90 mg IN DUMPING SYNDROME Phase 2