We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified October 2017 by Diva De Leon, Children's Hospital of Philadelphia
Sponsor:
ClinicalTrials.gov Identifier:
NCT00835328
First Posted: February 3, 2009
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Diva De Leon, Children's Hospital of Philadelphia
  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: None (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 Diva De Leon, 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 ]

Secondary Outcome Measures:
  • 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 ]

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

  • safety variable [ Time Frame: 9 hours ]
    Vital signs, adverse events

  • safety variables [ Time Frame: baseline ]
    physical examination


Estimated Enrollment: 20
Study Start Date: February 2009
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (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
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: February 2, 2009
First Posted: February 3, 2009
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Diva De Leon, 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