Clinical Trial: Effect of Exendin-(9-39) On Glucose Requirements To Maintain Euglycemia
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Role of GLP-1 In Congenital Hyperinsulinism: Effect Of Exendin-(9-39)On Glucose Requirements To Maintain Euglycemia
Brief Summary: 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
Detailed 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)
Sponsor: Diva De Leon
Current Primary Outcome: Glucose infusion rate during the last 2 hours of infusion of exendin-(9-39) [ Time Frame: 7-9 hours after start of infusion ]
Original Primary Outcome: Glucose infusion rate over a period of 12 hours [ Time Frame: 12 hours ]
Current Secondary Outcome:
- Plasma glucose 1 hour after initiation of infusion, [ Time Frame: 1 hour after start of infusion ]
- Insulin Level [ Time Frame: 0,1,5,9,hour during 9 hour infusion ]
- Plasma levels of exendin-(9-39) [ Time Frame: 1,5,9, +15,10,12,14 hour during and post infusion ]
- Betahydroxybutyrate levels [ Time Frame: 0,1,5,9, during 9 hour infusion ]
Original Secondary Outcome:
- Plasma glucagon levels [ Time Frame: 12 hours ]
- Plasma Insulin Level [ Time Frame: 12 hours ]
- Plasma levels of exendin-(9-39) [ Time Frame: 12 hours ]
Information By: Children's Hospital of Philadelphia
Dates:
Date Received: February 2, 2009
Date Started: February 2009
Date Completion: February 2018
Last Updated: April 26, 2017
Last Verified: April 2017
