Expired Study
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Philadelphia, Pennsylvania 19104


Purpose:

The purpose of this study is to examine the effect of exendin-(9-39)on glucose requirements to maintain euglycemia in infants with congenital hyperinsulinism unresponsive to medical therapy


Study summary:

This is an open label sudy to examine the effect of exendin-(9-39)on glucose requirements to maintain euglycemia in infants with congenital hyperinsulinism unresponsive to medical therapy and to determine therapeutic plasma levels,plasma half life and pharmacokinetics of exendin-(9-39)


Criteria:

Inclusion Criteria: - Confirmed diagnosis of congenital hyperinsulinism (based on clinical criteria: insulin, beta hydroxybutyrate, and/or free fatty acid plasma levels at the time of hypoglycemia, and/or glycemic response to glucagon at the time of hypoglycemia) - Age: from birth to 12 months - Failure to respond to diazoxide (defined as the failure to maintain blood glucose and octreotide (defined as the failure to maintain blood glucose ≥ 70 mg/dL without supraphysiologic rates of glucose infusion> 4-5 mg/Kg/min) Exclusion Criteria: - Evidence of a medical condition that might alter results, including active infection, kidney failure, severe liver dysfunction, severe respiratory or cardiac failure - Current therapy at the time of initiation of study procedures with medications that affect glucose metabolism, such as high dose glucocorticoids, ß-agonists, glucagon, diazoxide and octreotide. Subjects will be eligible to participate 4 hours after glucagon is discontinued, 24 hours after the last dose of octreotide and 72 hours after last dose of diazoxide, - Subjects with suspected Beckwith-Wiedemann syndrome or other syndromic forms of congenital hyperinsulinism.


NCT ID:

NCT00835328


Primary Contact:

Principal Investigator
Diva D De Leon, MD
Children's Hospital of Philadelphia


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19104
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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