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Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery

NCT03514576 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2018-07-05

No results posted yet for this study

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.

Conditions

  • Hypoglycemia, Reactive

Interventions

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.

Sponsors & Collaborators

  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Caroline C Øhrstrøm, MD · Department of Medicine, Zealand University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2018-08-01
Completion
2018-11-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03514576 on ClinicalTrials.gov