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Role of Glucagon-Like Peptide-1 in Postprandial Hypoglycemia

NCT01162499 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2017-10-23

Study results available
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Summary

It has been proposed that the rapid gastric emptying of carbohydrate containing fluids into the intestine causes hyperglycemia followed by reactive hypoglycemia. The investigators have shown that glucagon-like peptide-1 (GLP-1) secretion in response to a glucose load is increased in children with Post-prandial hypoglycemia (PPH). This is a proof of concept study to investigate the causative role of GLP-1 in the pathophysiology of PPH after fundoplication by evaluating the effects of GLP-1 receptor antagonism on metabolic variables after a mixed meal.

Hypothesis: In children with post-prandial hypoglycemia after fundoplication, antagonism of the GLP-1 receptor by exendin-(9-39) will elevate nadir blood glucose levels after a meal challenge and prevent post-prandial hypoglycemia.

Conditions

  • Postprandial Hypoglycemia

Interventions

DRUG

Exendin-(9-39)

IV infusion of exendin-(9-39) for 5 hours

OTHER

Vehicle

Normal saline (vehicle) infusion for 5 hours at 0.06 mL/kg/hr

Sponsors & Collaborators

  • Lester and Liesel Baker Foundation

    collaborator UNKNOWN

  • Diva De Leon

    lead OTHER

Principal Investigators

  • Diva De Leon, MD · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

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 NCT01162499 on ClinicalTrials.gov