Canagliflozin or acarbose versus placebo to ameliorate post‐bariatric hypoglycaemia – The HypoBar I randomized clinical trial protocol

Author:

Lobato Carolina B.12ORCID,Winding Clara Tornoe12,Bojsen‐Møller Kirstine N.13,Martinussen Christoffer1,Veedfald Simon2,Holst Jens J.24,Madsbad Sten1,Jørgensen Nils Bruun1,Dirksen Carsten13

Affiliation:

1. Department of Medicine Copenhagen University Hospital Amager and Hvidovre, Section of Endocrinology Hvidovre Denmark

2. Department of Biomedical Sciences Faculty of Health and Medical Sciences, University of Copenhagen Copenhagen Denmark

3. Department of Clinical Medicine Faculty of Health and Medical Sciences, University of Copenhagen Copenhagen Denmark

4. Faculty of Health and Medical Sciences University of Copenhagen, Novo Nordisk Foundation Centre for Basic Metabolic Research Copenhagen Denmark

Abstract

AbstractIntroductionPost‐bariatric hypoglycaemia (PBH) is a rare yet disabling clinical condition, mostly reported after Roux‐en‐Y gastric bypass (RYGB) surgery. RYGB is one of the most widely used and effective bariatric procedures. The pathophysiology of PBH remains unclear, and treatment options are limited in effectiveness and/or carry significant side effects. Acarbose slows carbohydrates digestion and absorption and is generally considered first‐line pharmacological treatment for PBH but its gastrointestinal side effects limit patient compliance. Canagliflozin inhibits intestinal and renal sodium‐dependent glucose absorption and reduces postprandial excursions of glucose, insulin and incretins after RYGB – effects that could be beneficial in ameliorating PBH.AimsThe trial aims to investigate how blood glucose levels are affected during daily living in subjects with PBH during treatment with canagliflozin or acarbose compared with placebo, and to study the meal‐induced entero‐endocrine mechanisms implied in the treatment responses.MethodsIn a double‐blinded, randomized, crossover clinical trial, HypoBar I will investigate the effectiveness in reducing the risk of PBH, safety, ambulatory glucose profile and entero‐endocrine responses when PBH is treated with canagliflozin 300 mg twice daily during a 4‐week intervention period, compared with acarbose 50 mg thrice daily or placebo.Ethics and DisseminationHypoBar I is approved by the Local regulatory entities. Results will be published in peer‐reviewed journals.ConclusionIf effective, well‐tolerated and safe, canagliflozin could be a novel treatment for people with PBH. HypoBar I might also unravel new mechanisms underlying PBH, potentially identifying new treatment targets.Trial RegistrationEudraCT number 2022–000157‐87.

Funder

Danish Diabetes and Endocrine Academy

'la Caixa' Foundation

Publisher

Wiley

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