Study of Canakinumab to Treat Postprandial Hypoglycemia After Bariatric Surgery

What this Trial Is About

Researchers are evaluating the effects of canakinumab compared to placebo in patients experiencing postprandial hypoglycemia after bariatric surgery. This condition can significantly reduce quality of life and currently has no approved drug treatments. The trial aims to determine if canakinumab can improve mental and physical health-related quality of life and reduce hypoglycemic episodes. Participants will receive either a single subcutaneous injection of 150 mg canakinumab or a placebo injection of saline solution. The study includes a 10-day screening phase using a blinded continuous glucose monitoring system to confirm hypoglycemia, followed by a 28-day treatment period with three study visits for monitoring and data collection. After treatment, participants will have a follow-up visit two months later to assess longer-term effects. During the study, participants will wear glucose monitors, keep diaries, and report any adverse events. Researchers will measure changes in quality of life, frequency of hypoglycemic events, hypoglycemia symptoms, fear of hypoglycemia, glucose patterns, body weight, and safety outcomes. The total participation time is up to four months, including screening, treatment, and follow-up assessments.

Canakinumab for the Treatment of Postprandial Hypoglycemia