Treatment of Hypoglycemia Following Gastric Bypass Surgery

What this study is testing ClinicalTrials.gov NCT02527993 ↗

Description as written by the study sponsor.

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.

Treatments tested

• Glucobay (acarbose) also known as glucobay Drug

  Se arm description

• Januvia (sitagliptin) also known as Januvia Drug

  Se arm description

• Verapamil HEXAL (verapamil) also known as Verapamil HEXAL Drug

  Se arm description

• Victoza (liraglutide) also known as Victoza Drug

  Se arm description

• Signifor (pasireotide) also known as Signifor Drug

  Se arm description

• Continuous glucose monitoring (CGM) Device

  Continuous glucose monitoring will be performed during 6 days of the treatment period.

• Meal tolerance test (MTT) Dietary supplement

  A meal tolerance test will be performed at the end of the treatment period. The subjects will consume the liquid meal at baseline and blood will be drawn for continuous blood sampling.