drugset / Trial / NCT02527993

Treatment of Hypoglycemia Following Gastric Bypass Surgery

NCT02527993

Phase 4 Completed 11 enrolled Zealand University Hospital
RandomizedCrossoverOpen-labelTreatment

Summary

Obesity is increasing worldwide and consequently the need for efficient treatment opportunities. Roux-en-Y gastric bypass (RYGB) is one of the most commonly performed bariatric procedures used in the treatment of severe obesity. The surgery results in significant and sustained weight loss and has a beneficial effect on blood glucose regulation. However, some patients experience the syndrome postprandial hyperinsulinemic hypoglycemia years after the operation, with symptoms varying from mild dizziness to confusion, loss of consciousness and seizures. Larger insulin and glucagon-like peptide 1 (GLP-1) responses to an oral glucose load are believed to play a role in the syndrome, which is not yet fully understood. There are no current treatment guidelines beside dietary recommendations. The purpose of this study is to compare different pharmacological treatments on daily blood glucose variations as well as postprandial hormonal and autonomous changes in subjects with symptoms of postprandial hyperinsulinemic hypoglycemia after RYGB.

Timeline

Start
2015-10
Primary completion
2017-04-08
Completion
2017-04-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Acarbose Unknown 50 mg Oral
Subject Liraglutide Peptide 1.2 mg Subcutaneous
Subject Pasireotide Other / unclassified 300 ug Subcutaneous
Subject Sitagliptin Small molecule 100 mg Oral
Subject Verapamil Other / unclassified 120 mg Oral