Status:
COMPLETED
Role of Glucagon-Like Peptide-1 in Postprandial Hypoglycemia
Lead Sponsor:
Diva De Leon
Collaborating Sponsors:
Lester and Liesel Baker Foundation
Conditions:
Postprandial Hypoglycemia
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief 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 gluc...
Detailed Description
PPH is a frequent complication of fundoplication in children. The mechanism responsible for the PPH is poorly understood, but involves an exaggerated insulin response to a meal and subsequent hypoglyc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01162499
Start Date
April 1 2010
End Date
December 1 2014
Last Update
October 23 2017
Active Locations (1)
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1
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104