Status:
TERMINATED
Effect of Exendin (9-39) on Glucose Requirements to Maintain Euglycemia
Lead Sponsor:
Diva De Leon
Conditions:
Congenital Hyperinsulinism
Eligibility:
All Genders
Up to 12 years
Phase:
PHASE1
PHASE2
Brief Summary
The primary aim of this study is to evaluate the effect of Exendin (9-39) on glucose requirements to maintain euglycemia in pediatric patients with congenital hyperinsulinism (CHI) who have failed med...
Detailed Description
This study will enroll infants with congenital hyperinsulinism owing to KATP channel mutations who are unresponsive to medical therapy and will require a pancreatectomy to control hypoglycemia from a ...
Eligibility Criteria
Inclusion
- Confirmed clinical diagnosis of congenital hyperinsulinism
- Infants less than 12 months of age at study enrollment
- Failure to respond to treatment with diazoxide
Exclusion
- Evidence of a medical condition that might alter results, including kidney failure, severe liver dysfunction, severe respiratory or cardiac failure
- Treatment with medications that may affect glucose metabolism at the time of initiation of study procedures, including:
- Treatment with glucagon 4 hours prior to infusion (T=0)
- Treatment with octreotide 24 hours prior to infusion (T=0)
- Treatment with diazoxide 72 hours prior to infusion (T=0)
- Suspected Beckwith-Wiedemann syndrome or other syndromic forms of congenital hyperinsulinism.
Key Trial Info
Start Date :
August 26 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2017
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00835328
Start Date
August 26 2009
End Date
January 28 2017
Last Update
June 1 2020
Active Locations (1)
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1
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104