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

NCT ID: NCT00798590

Last Updated: 2017-07-02

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-06-30

Brief Summary

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The goal of this present proposal is to examine the efficacy of GLP-1 administered to control blood glucose in critically ill patients.

Detailed Description

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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.

Conditions

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Critically Ill Hypoglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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GLP-1

Group Type EXPERIMENTAL

Glucagon-Like Peptide-1

Intervention Type DRUG

5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.

Saline

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.

Interventions

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Glucagon-Like Peptide-1

5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.

Intervention Type DRUG

Saline

5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.

Intervention Type DRUG

Other Intervention Names

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GLP-1

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Society of Critical Care Medicine

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dariush Elahi, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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NA_00022551

Identifier Type: -

Identifier Source: org_study_id

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