gms | German Medical Science

Background/research question: Bariatric surgery emerged to be an increasingly used treatment option for morbid obesity with postprandial hypoglycemia as major possible side effect. This may be asymptomatic but sometimes serious and appears to be in part also relevant for weight regain. We found in a recent study two novel mechanisms and treatment modalities that may be useful for postbariatric hypoglycemia which we aim to explore in a randomized trial. However, it is unclear which primary outcome would be most useful and patient-relevant. Sometimes used surrogate outcomes based on responses in standardized mixed-meal tests appear to not reflect patient needs.

Methods: From a clinical perspective, we regarded two outcomes as most patient-relevant and also most useful to understand the mechanism of the novel treatments in this condition. Quality-of-life and frequency of hypoglycemic episodes. To obtain a better understanding of the patient perspective, including the value of these outcomes, the time-point of their measurement, and acceptable study settings, we developed an online questionnaire and collect information on patient-preferences, demographic and health-related data. The study was approved by the local ethics committee and will be conducted in Swiss bariatric centers.

Preliminary/expected results, outlook: The questionnaire may help in identifying a preferred primary outcome and optimize the trial design for a drug evaluation trial. We expect to present data at the EBM congress in February 2020.

Competing interests: No conflicts of interest.