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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 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: February 18, 2015
Last verified: February 2015
  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)
Other: placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover 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 during the last 2 hours of infusion of exendin-(9-39) [ Time Frame: 7-9 hours after start of infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma glucose 1 hour after initiation of infusion, [ Time Frame: 1 hour after start of infusion ] [ Designated as safety issue: No ]
  • Insulin Level [ Time Frame: 0,1,5,9,hour during 9 hour infusion ] [ Designated as safety issue: No ]
  • Plasma levels of exendin-(9-39) [ Time Frame: 1,5,9, +15,10,12,14 hour during and post infusion ] [ Designated as safety issue: No ]
  • Betahydroxybutyrate levels [ Time Frame: 0,1,5,9, during 9 hour infusion ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Safety variables [ Time Frame: 2 days (baseline, study end) ] [ Designated as safety issue: Yes ]
    12 lead electrocardiograms,laboratory safety test(hematology, chemistry and urinalysis)

  • safety variable [ Time Frame: 9 hours ] [ Designated as safety issue: Yes ]
    Vital signs, adverse events

  • safety variables [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    physical examination


Estimated Enrollment: 20
Study Start Date: February 2009
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: exendin-(9-39)
exendin-(9-39) 1000-30000pmol/kg/min (0.2-6mg/kg/hr) Intravenous infusion over 9 hours
Drug: exendin-(9-39)
exendin-(9-39) 1000-30000pmol/kg/min (0.2-6mg/kg/hr) Intravenous infusion over 9 hours
Other Name: Exendin-(9-39)
Placebo Comparator: placebo
intravenous infusion of normal saline over 9 hours
Other: placebo
normal saline Intravenous infusion over 9 hours

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 clinical criteria: 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 ( 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.
  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. Associate 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: February 18, 2015
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:
Congenital Hyperinsulinism
Hyperinsulinism
Digestive System Diseases
Glucose Metabolism Disorders
Hypoglycemia
Infant, Newborn, Diseases
Metabolic Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on April 19, 2015