Evidence mapPaperPMID 41810556Full record

Trial reportDiabetes, obesity & metabolism2026

Acarbose or Canagliflozin vs. Placebo to Ameliorate Post-Bariatric Hypoglycaemia: The Clinical Outcomes of the HypoBar I Randomised Clinical Trial.

Carolina B Lobato, Clara Tornøe Winding, Kirstine N Bojsen-Møller, Bolette Hartmann, Christoffer Martinussen, Simon Veedfald, Jens J Holst, Sten Madsbad, Nils Bruun Jørgensen, Carsten Dirksen

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Carolina B LobatoDepartment of Medicine, Copenhagen University Hospital - Amager and Hvidovre, Section of Endocrinology, Hvidovre, Denmark.ORCID https://orcid.org/0000-0003-3708-6859
Clara Tornøe WindingDepartment of Medicine, Copenhagen University Hospital - Amager and Hvidovre, Section of Endocrinology, Hvidovre, Denmark.
Kirstine N Bojsen-MøllerDepartment of Medicine, Copenhagen University Hospital - Amager and Hvidovre, Section of Endocrinology, Hvidovre, Denmark.
Bolette HartmannDepartment of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Christoffer MartinussenDepartment of Medicine, Copenhagen University Hospital - Amager and Hvidovre, Section of Endocrinology, Hvidovre, Denmark.
Simon VeedfaldDepartment of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Jens J HolstDepartment of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.ORCID https://orcid.org/0000-0001-6853-3805
Sten MadsbadDepartment of Medicine, Copenhagen University Hospital - Amager and Hvidovre, Section of Endocrinology, Hvidovre, Denmark.ORCID https://orcid.org/0000-0002-5017-1815
Nils Bruun JørgensenDepartment of Medicine, Copenhagen University Hospital - Amager and Hvidovre, Section of Endocrinology, Hvidovre, Denmark.
Carsten DirksenDepartment of Medicine, Copenhagen University Hospital - Amager and Hvidovre, Section of Endocrinology, Hvidovre, Denmark.

Funding

Danish Diabetes Academy PhD013-20Hvidovre Hospital's Strategic Research Foundation"la Caixa" Foundation LCF/BQ/EU21/11890081Novo Nordisk Foundation NNF17SA0031406Novo Nordisk Foundation NNF23SA0084103Novo Nordisk Foundation NNF23SA0087869
6 · The paper itself

Abstract

aimsTreatment options for post-bariatric hypoglycaemia (PBH) are empirical. We aimed to investigate the efficacy and safety of acarbose and canagliflozin for the treatment of PBH. MATERIALS AND

methodsWe performed a randomised, double-blinded, cross-over, placebo-controlled clinical trial where placebo, acarbose 50 mg thrice daily, and canagliflozin 300 mg twice daily were administered for 4 weeks. Treatment effects on blood glucose were monitored through blinded continuous glucose monitoring (CGM) for 10 days at the end of each intervention along with collection of patient-reported outcomes. The primary outcome was the percentage of time below range during CGM (interstitial glucose below 3.9 mM/70 mg/dL).

resultsEleven participants with Roux-en-Y gastric bypass and documented PBH completed the trial. When compared with placebo, neither canagliflozin nor acarbose reduced the percentage of time below range (primary outcome, time below 3.9 mmol/L, median (IQR): screening 2.6 (0.7-5.1)%, placebo 1.2 (0.5-2.4)%, acarbose 1.1 (0.8-1.7)% and canagliflozin 0.8 (0.5-3.4)%). Both interventions, however, showed exploratory improvements in pre-specified secondary outcomes, including time in range and glycaemic variability, as well as a reduction of symptoms of hypoglycaemia and frequency of symptomatic hypoglycaemic events, particularly with canagliflozin. Acarbose was associated with moderate and common side effects that caused treatment discontinuation in one participant. For both treatments, no severe adverse events were documented.

conclusionsHypoBar I is the first randomised, placebo-controlled study of the treatment of PBH with acarbose or canagliflozin. Reduction in time below range was not achieved by either treatment; nevertheless, improvements in hypothesis-generating secondary findings merit further investigation and validation. EudraCT number 2022-000157-87.

Indexed as

AcarboseCanagliflozinGastric BypassHypoglycemiaHypoglycemic AgentsPostoperative ComplicationsAdultBlood GlucoseContinuous Glucose MonitoringCross-Over StudiesDouble-Blind MethodFemaleHumansMaleMiddle AgedTreatment OutcomeAcarboseBlood GlucoseCanagliflozinHypoglycemic Agentsbariatric surgerycanagliflozincontinuous glucose monitoring (CGM)hypoglycaemiapatient reported outcomesrandomised trial

Identifiers

PMID41810556
PMCPMC13071188

What Socratic holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.