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Effect of GLP - 1 (7-36 Amide) on Myocardial Function Following Coronary Artery Bypass (CABG) Surgery (GLP-1 CABG)

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ClinicalTrials.gov Identifier: NCT00966654
Recruitment Status : Terminated (PI left JHU)
First Posted : August 27, 2009
Results First Posted : July 12, 2017
Last Update Posted : July 12, 2017
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: CABG
Interventions: Drug: Placebo
Drug: GLP-1 (7-36) amide

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
GLP-1

GLP-1 (7-36) amide

GLP-1 (7-36) amide: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours.

OR

Placebo (saline)


Participant Flow:   Overall Study
    GLP-1
STARTED   12 
COMPLETED   0 
NOT COMPLETED   12 
Study was terminated,PI left institution                12 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Although 12 participants were enrolled in this study, their assignment to study arm/group, if any, is unknown. The P.I. has left the institution and neither he, nor further data (if any), are available.

Reporting Groups
  Description
All Study Participants

GLP-1 (7-36) amide

GLP-1 (7-36) amide: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours.


Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age, Customized 
[Units: Participants]
 
Age, years (18-75)   12 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      5  41.7% 
Male      7  58.3% 
Region of Enrollment 
[Units: Participants]
 
United States   12 


  Outcome Measures

1.  Primary:   Left Ventricular Systolic Function: Pulmonary Capillary Wedge Pressure   [ Time Frame: 2 years ]

2.  Secondary:   Insulin Infusion Requirements   [ Time Frame: 72 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Johns Hopkins University Clinical Trials Program
Organization: Johns Hopkins University School of Medicine
phone: 410-550-6484
e-mail: registerclinicaltrials@jhmi.edu



Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00966654     History of Changes
Other Study ID Numbers: NA_00013802
First Submitted: August 26, 2009
First Posted: August 27, 2009
Results First Submitted: May 1, 2017
Results First Posted: July 12, 2017
Last Update Posted: July 12, 2017