Diabetes, obesity & metabolism · 2026
Acarbose or Canagliflozin vs. Placebo to Ameliorate Post-Bariatric Hypoglycaemia: The Clinical Outcomes of the HypoBar I Randomised Clinical Trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Lobato Carolina B, Winding Clara Tornøe, Bojsen-Møller Kirstine N, Hartmann Bolette, Martinussen Christoffer, Veedfald Simon, Holst Jens J, Madsbad Sten, Jørgensen Nils Bruun, Dirksen Carsten
Аннотация
AIMS: Treatment 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 METHODS: We 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).
RESULTS: Eleven 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.
CONCLUSIONS: HypoBar 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.
MATERIALS AND METHODS: We 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).
RESULTS: Eleven 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.
CONCLUSIONS: HypoBar 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.