NCT03514576

Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Zealand University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Postprandial hyperinsulinemic hypoglycemia is a well-known and potentially severe complication of Roux-en-Y gastric bypass (RYGB), and the treatment options are limited. Pasireotide has shown to be effective in preventing hypoglycemia in RYGB operated subjects, however treatment often leads to increased hyperglycemia. The purpose of this study is to investigate two doses of pasireotide that are lower than doses previously used in RYGB operated subjects with postprandial hyperinsulinemic hypoglycemia.

Detailed description

With the growing number of RYGB operated subjects the attention on complications such as postprandial hyperinsulinemic hypoglycemia (PHH) has increased. PHH is characterized by increased glycemic variability and hypoglycemic episodes occurring 2-3 hours after a meal together with a markedly increase in insulin and glucagon-like-peptide 1 (GLP-1) levels. Symptoms vary from dizziness and palpitations to confusion, loss of consciousness and convulsions. At present there are few treatment options available for RYGB patients with PHH and most of them rely on dietary changes that are difficult to adhere to. Pasireotide has been shown to reduce hypoglycemia in RYGB operated subjects with PHH, but often leads to increased hyperglycemia as well. The purpose of the study is to investigate two doses of pasireotide in RYGB operated subjects with PHH. Each subject will undergo two meal tolerance test (MTT) preceded by either 75 µg or 150 µg of pasireotide. Blood samples will be collected throughout the meal test at predefined time points and will be analyzed for glucose, insulin, C-peptide, GLP-1 and glucagon levels.

Conditions

• Hypoglycemia, Reactive

Interventions

Type	Name	Description
DRUG	Pasireotide 0.3 MG/ML	See arm description
DIAGNOSTIC_TEST	Meal tolerance test (MTT)	Subjects will consume the liquid meal at baseline and blood will be drawn for continuous blood sampling.

Timeline

• Start date: 2018-06-01
• Primary completion: 2018-08-01
• Completion: 2018-11-01
• First posted: 2018-05-02
• Last updated: 2018-07-05

Locations

1 site across 1 country: Denmark