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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2010 by Johns Hopkins University.
Recruitment status was:  Enrolling by invitation
Society of Critical Care Medicine
Information provided by:
Johns Hopkins University Identifier:
First received: November 25, 2008
Last updated: March 25, 2010
Last verified: March 2010
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: Single Group Assignment
Masking: Double Blind (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 # of hypoglycemic events between GLP-1/placebo treatment;Amount of meds in the control of homeostasis;Death in the ICU/in-hospital;Time of ICU stay/hospitalization;ICU infection rate;Time of ventilator support to time of extubation. [ Time Frame: 2 years ]

Estimated Enrollment: 180
Study Start Date: December 2008
Estimated Study Completion Date: June 2011
Estimated 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% 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.

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

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.
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Please refer to this study by its identifier: NCT00798590

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

Responsible Party: Dariush Elahi, Johns Hopkins University School of Medicine Identifier: NCT00798590     History of Changes
Other Study ID Numbers: NA_00022551
Study First Received: November 25, 2008
Last Updated: March 25, 2010

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

Additional relevant MeSH terms:
Critical Illness
Glucose Metabolism Disorders
Metabolic Diseases
Disease Attributes
Pathologic Processes
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins processed this record on June 26, 2017