NCT01162499

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

Completed NA Results posted Last updated 21 September 2017

What this trial tests

NA trial testing Exendin-(9-39) in Postprandial Hypoglycemia in 7 participants. Completed in 1 December 2014.

Timeline

1 April 2010

Primary endpoint
1 December 2014

1 December 2014

Quick facts

Lead sponsor	Diva De Leon
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	7
Start date	1 April 2010
Primary completion	1 December 2014
Estimated completion	1 December 2014
Sites	1 location across United States

Drugs / interventions tested

• Exendin-(9-39)
• Vehicle

Conditions studied

• Postprandial Hypoglycemia — all drugs for Postprandial Hypoglycemia →

Sponsor

Diva De Leon

Who can join

Adults 6 Months to 18, any sex, with Postprandial Hypoglycemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Mean Plasma Glucose Area Under the Curve (AUC 0-3h)
  Time frame: 3 hours
  To examine the effect of Exendin-(9-39) on plasma glucose levels samples were collected at various time points before and during the infusion \[Exendin-(9-39) or vehicle\] including: 60 minutes before the start of the infusion, again at the start of the infusion (time 0), and then every 30 minutes until 3 hours after the start of the meal. Using this information, the mean plasma glucose area under

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Postprandial Hypoglycemia in Children after Gastric Surgery: Clinical Characterization and Pathophysiology.
   Calabria AC, Charles L, Givler S, De León DD. · · 2016 · cited 20× · PMID 26694545 · DOI 10.1159/000442155