Effect of Exendin-(9-39) On Glucose Requirements To Maintain Euglycemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Children's Hospital of Philadelphia
Sponsor:
Information provided by (Responsible Party):
Diva De Leon, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00835328
First received: February 2, 2009
Last updated: July 30, 2014
Last verified: July 2014
  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


Condition Intervention Phase
Congenital Hyperinsulinism
Drug: Exendin-(9-39)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Role of GLP-1 In Congenital Hyperinsulinism: Effect Of Exendin-(9-39)On Glucose Requirements To Maintain Euglycemia

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Glucose infusion rate over a period of 6 hours [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma glucagon levels [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Plasma Insulin Level [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Plasma levels of exendin-(9-39) [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2009
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: exendin-(9-39) Drug: Exendin-(9-39)
500 pmol/kg/min as an intravenous infusion over 6 hours
Other Name: Exendin-(9-39)

Detailed Description:

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)

  Eligibility

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of congenital hyperinsulinism (based on insulin, beta hydroxybutyrate, and free fatty acid plasma levels at the time of hypoglycemia, and glycemic response to glucagon at the time of hypoglycemia)
  • Age: from birth to 12 months
  • Failure to respond to diazoxide and octreotide (defined as the failure to maintain blood glucose > 70 mg/dL without supraphysiologic rates of glucose infusion:> 4-5 mg/Kg/min)
  • Schedule for pancreatectomy

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 with medications that affect glucose metabolism, such as glucocorticoids, ß-agonists, glucagon, diazoxide and octreotide. Subjects will be eligible to participate 48 hrs after the last dose of octreotide and 72 hours after last dose of diazoxide
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00835328

Contacts
Contact: Stephanie Givler, BS,CCRC 267-426-7622 givler@email.chop.edu

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Stephanie Givler, BS,CCRC    267-426-7622    givler@email.chop.edu   
Principal Investigator: Diva D De Leon, MD         
Sub-Investigator: Charles A Stanley, MD         
Sponsors and Collaborators
Diva De Leon
Investigators
Principal Investigator: Diva D De Leon, MD Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Diva De Leon, M.D. Assistant Professor of Pediatrics, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00835328     History of Changes
Other Study ID Numbers: 2008-10-6256, R56DK083670-02
Study First Received: February 2, 2009
Last Updated: July 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital of Philadelphia:
hyperinsulinism
hypoglycemia
ATP- sensitive potassium channel (KATP)

Additional relevant MeSH terms:
Hyperinsulinism
Congenital Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pancreatic Diseases
Digestive System Diseases
Infant, Newborn, Diseases
Hypoglycemia

ClinicalTrials.gov processed this record on September 22, 2014