NCT03406312

Validation of a Diagnostic Tool for Postprandial Hypoglycaemia in Patients After Roux en Y Gastric Bypass Surgery

European Dumping Study: Validation of a Diagnostic Tool for Postprandial Hypoglycaemia in Patients After Roux en Y Gastric Bypass Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: University Ghent · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Roux-en-Y gastric bypass (RYGB) leads to weight reduction but has also some unwanted side effects. A part of this population will develop postprandial reactive hypoglycemia (PPRH). At this moment no validated diagnostic tool exists for PPRH. The aim of this study is to prove an association between the Sigstad´s Score and the lowest postprandial glucose level in patients after RYGB surgery. This is investigated using a liquid mixed meal tolerance test (LMMTT). As a secondary hypothesis, associations between Edinburgh Hypoglycemia Scale (EHS) and postprandial glucose levels are investigated. Furthermore, changes of insulin and GLP-1 levels during the test are analysed. Patient characteristics including co-morbidities are studied as possible influencing parameters. Moreover, a healthy control group is included to validate the results. Finally, a flowchart/diagnostic method will be proposed for diagnosing patients who had a RYBG surgery with symptoms suggestive of PPRH. Besides the LMMTT, participants at the Ghent University Hospital will undergo additional tests such as a solid mixed meal tolerance test (SMMTT) and continuous glucose monitoring (CGM). Associations between Sigstad Score, EHS and the lowest glucose measured during CGM and SMMTT will be investigated and compared to the results of the LMMTT.

Conditions

• Post Prandial Hypoglycemia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Post Prandial Hypoglycemia test	three test assessing hypoglycemia will be used: liquid mixed meal tolerance test, solid mixed meal tolerances test, continuous glucose monitoring

Timeline

• Start date: 2017-06-01
• Primary completion: 2020-05-05
• Completion: 2020-05-05
• First posted: 2018-01-23
• Last updated: 2021-12-01

Locations

1 site across 1 country: Belgium