Role of Glucagon-Like Peptide-1 in Postprandial Hypoglycemia

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Diva De Leon
• Collaborator: Lester and Liesel Baker Foundation
• Treatments: Glucagon; Glucagon-Like Peptide 1

Criteria

Inclusion Criteria:

• Children (6 months-18 years) who have had fundoplication or other gastric surgeries, irrespective of duration of postoperative period

• Weight > 6.5 Kg

• Signs and/or symptoms of PPH: post-prandial blood glucose levels of < 70 mg/dL ; symptoms including but not limited to feeding difficulties, irritability, nausea, diarrhea, pallor, diaphoresis, weakness, and lethargy after meals

Exclusion Criteria:

• Evidence of a medical condition that might alter results or compromise the elimination of the peptide, including, but not limited to: active infection, kidney failure (creatinine ≥ 2x above upper limit for age), severe liver dysfunction (AST or ALT ≥ 5x upper limit of normal for AST or ALT), severe respiratory or cardiac failure

• Other disorders of glucose regulation such as diabetes mellitus, congenital hyperinsulinism, glycogen storage disease

• Current use (within 1 week) of medications that may alter glucose homeostasis such as glucocorticoids, diazoxide, octreotide

• Use of antihistaminics within 10 days prior to the study

• Moderate and severe anemia defined as a hemoglobin < 10g/dL

• Pregnancy

• Milk and soy protein allergy