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The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition

This study has been terminated.
(PI left JHU)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00686972
First Posted: May 30, 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.
Information provided by (Responsible Party):
Johns Hopkins University
Results First Submitted: May 1, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition: Bariatric Surgery
Intervention: Drug: GLP-1

  Participant Flow
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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
Glucagon Like Peptide 1 -GLP-1

5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.

GLP-1: 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.


Participant Flow:   Overall Study
    Glucagon Like Peptide 1 -GLP-1
STARTED   51 
COMPLETED   0 
NOT COMPLETED   51 
P.I, Left institution. Study terminated                51 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
GLP-1

5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.

GLP-1: 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.


Baseline Measures
   GLP-1 
Overall Participants Analyzed 
[Units: Participants]
 51 
Age, Customized 
[Units: Participants]
 
>=21 and <=65   51 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      43  84.3% 
Male      8  15.7% 
Region of Enrollment 
[Units: Participants]
 
United States   51 


  Outcome Measures

1.  Primary:   Insulin Secretion   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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: NCT00686972     History of Changes
Other Study ID Numbers: NA_00004876
First Submitted: May 27, 2008
First Posted: May 30, 2008
Results First Submitted: May 1, 2017
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017