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The Efficacy of Glucagon Like Peptide (GLP) - 1(7-36) Amide for Glycemic Control in Critically Ill Patients

This study has been terminated.
(PI left JHU)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00798590
First Posted: November 26, 2008
Last Update Posted: July 2, 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. Read our disclaimer for details.
Collaborator:
Society of Critical Care Medicine
Information provided by (Responsible Party):
Johns Hopkins University
  Purpose
The goal of this present proposal is to examine the efficacy of GLP-1 administered to control blood glucose in critically ill patients.

Condition Intervention Phase
Critically Ill Hypoglycemia Drug: Glucagon-Like Peptide-1 Drug: Saline Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of GLP - 1 (7-36) Amide for Glycemic Control in Critically Ill Surgical Patients

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • To Compare the Composite Overall Amount of Insulin Used With GLP-1 vs. Placebo to Reach and Maintain the ICU-specific Target Glucose Range. [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Compare the Number of Hypoglycemic Events Between GLP-1/Placebo Treatment [ Time Frame: 2 years ]

Enrollment: 19
Study Start Date: December 2008
Study Completion Date: June 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GLP-1 Drug: Glucagon-Like Peptide-1
5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.
Other Name: GLP-1
Placebo Comparator: Saline Drug: Saline
5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.

Detailed Description:
All patients whom on admission to the ICU (surgical, burn, & cardiac) who are expected to receive intensive insulin therapy for at least 72 hours are eligible to be enrolled. Once enrolled, the patients will be randomized to one of two groups: the experimental (intravenous GLP-1 infusion for 72 hours) or control groups (intravenous 0.9% sodium chloride (NaCl) infusion for 72 hours) in a double masked fashion. While enrolled, all patients will receive standard-of-care insulin therapy. Both groups will be maintained on the standard ICU specific protocol for glucose control.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women age > 21 to 75 years of age.
  • All subjects who meet ICU specific criteria for inclusion in their glucose protocol and placed on insulin infusion protocol as standard of care.
  • Able to obtain patient or proxy consent.

Exclusion Criteria:

  • Current diagnosis of malignancy.
  • Type 1 diabetes.
  • Inability to obtain informed consent.
  • On any Phase 1 trial.
  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): NCT00798590


Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Society of Critical Care Medicine
Investigators
Principal Investigator: Dariush Elahi, PhD Johns Hopkins University
  More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00798590     History of Changes
Other Study ID Numbers: NA_00022551
First Submitted: November 25, 2008
First Posted: November 26, 2008
Results First Submitted: May 1, 2017
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017
Last Verified: June 2017

Keywords provided by Johns Hopkins University:
Intensive insulin therapy (IIT)
Insulin infusion
Tight glycemic control
Intensive Care Units

Additional relevant MeSH terms:
Critical Illness
Hypoglycemia
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins