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Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Pre-diabetes (PEGIR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02023918
First Posted: December 30, 2013
Last Update Posted: April 24, 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:
San Francisco General Hospital
Information provided by (Responsible Party):
University of California, San Francisco
Results First Submitted: November 9, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Diabetes
Metabolic Syndrome
Insulin Resistance
Intervention: Drug: pegvisomant

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Pegvisomant Arm

Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.

pegvisomant: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.


Participant Flow:   Overall Study
    Pegvisomant Arm
STARTED   6 
COMPLETED   6 
NOT COMPLETED   0 



  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.
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Reporting Groups
  Description
Pegvisomant Arm pegvisomant: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.

Baseline Measures
   Pegvisomant Arm 
Overall Participants Analyzed 
[Units: Participants]
 6 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      6 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.5  (3.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      6 100.0% 
Region of Enrollment 
[Units: Participants]
 
United States   6 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Insulin Sensitivity   [ Time Frame: 28 days ]

2.  Secondary:   Lipolysis   [ Time Frame: 28 days ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Ethan Weiss
Organization: UCSF
phone: 4155140819
e-mail: ethan.weiss@ucsf.edu



Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02023918     History of Changes
Other Study ID Numbers: WI178028
First Submitted: December 24, 2013
First Posted: December 30, 2013
Results First Submitted: November 9, 2016
Results First Posted: March 13, 2017
Last Update Posted: April 24, 2017