N/A
N=7
Role of Glucagon-Like Peptide-1 in Postprandial Hypoglycemia
Postprandial Hypoglycemia
Bottom Line
View on ClinicalTrials.gov: NCT01162499 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Mean Plasma Glucose Area Under the Curve (AUC 0-3h) — 22,192.5; 25,207.1; 21,715.9 mg*min/dl
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exendin-(9-39) (Drug); Vehicle (Other)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Diva De Leon
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Plasma Glucose Area Under the Curve (AUC 0-3h) |
22,192.5; 25,207.1; 21,715.9 | — |
| SECONDARY Mean Plasma Insulin Area Under the Curve (AUC 0-3h) |
14,695.85; 9,058.5; 19,435.4 | — |
| SECONDARY Mean Acetaminophen Plasma Concentration Area Under the Curve (AUC 0-3h) |
3,387.5; 3,742.8; 3,436.6 | — |
| SECONDARY Peak Plasma Glucagon-like Peptide-1 (GLP-1) Concentration During Infusion |
65.8; 75.2; 72.8 | — |
| SECONDARY Peak Glucagon Concentration During Infusion |
127.5; 145.7; 114.0 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01162499). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.