CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 7 enrolled
Drug / intervention
Exendin-(9-39) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01162499
NCT01162499N/ACompleted

Role of Glucagon-Like Peptide-1 in Postprandial Hypoglycemia After Nissen Fundoplication: Studies With the GLP-1 Receptor Antagonist Exendin-(9-39)

Diva De Leon·interventional·Posted Jul 14, 2010·Updated Oct 23, 2017

In Brief

A clinical study evaluating Exendin-(9-39) and Vehicle for Postprandial Hypoglycemia. Completed, enrolled 7 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 14, 2010
Enrollment StartApr 1, 2010
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 16.0 years ago

Interventions

Exendin-(9-39)drug

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

Vehicleother

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