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Pilot Study of Bydureon to Treat Diabetes in HIV-infected Adults

This study has been terminated.
(This study was terminated after 6 patients due to loss of funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01791465
First Posted: February 15, 2013
Last Update Posted: March 10, 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:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
John R. Koethe, Vanderbilt University
Results First Submitted: May 5, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Human Immunodeficiency Virus Infection
Diabetes Mellitus
Intervention: Drug: extended-release exenatide

  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
Six HIV-infected participants recruited from the Vanderbilt Comprehensive Care Clinic between April 17, 2013 and May 6, 2016.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No consented participants were excluded prior to group assignment

Reporting Groups
  Description
Bydureon Treatment Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons

Participant Flow:   Overall Study
    Bydureon Treatment
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.
No text entered.

Reporting Groups
  Description
Bydureon Treatment Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide

Baseline Measures
   Bydureon Treatment 
Overall Participants Analyzed 
[Units: Participants]
 6 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 51 
 (45 to 70) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  33.3% 
Male      4  66.7% 
Region of Enrollment 
[Units: Participants]
 
United States   6 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Serum Highly-sensitive C-reactive Protein (hsCRP) Levels at Baseline and 16 Weeks   [ Time Frame: baseline and 16 weeks ]

2.  Primary:   Serum Interleukin 6 (IL-6) at Levels at Baseline and 16 Weeks   [ Time Frame: baseline and 16 weeks ]

3.  Secondary:   Serum Soluble Tumor Necrosis Factor Alpha (TNF-α) Levels at Baseline and 16 Weeks   [ Time Frame: baseline and 16 weeks ]

4.  Secondary:   Serum Macrophage Chemotactic Protein-1 (MCP-1) Levels at Baseline and 16 Weeks   [ Time Frame: baseline and 16 weeks ]

5.  Secondary:   Serum Macrophage Inflammatory Protein 1 Alpha (MIP-1 Alpha) Levels at Baseline and 16 Weeks   [ Time Frame: baseline and 16 weeks ]

6.  Secondary:   Oral Glucose Insulin Sensitivity (OGIS) at Baseline and 16 Weeks   [ Time Frame: baseline and 16 weeks ]

7.  Secondary:   Serum Adipokine Leptin Levels at Baseline and 16 Weeks   [ Time Frame: baseline and 16 weeks ]

8.  Secondary:   Body Mass Index at Baseline and 16 Weeks   [ Time Frame: 16 weeks ]

9.  Secondary:   Serum TNF-a Receptor 1 Levels at Baseline and 16 Weeks   [ Time Frame: baseline and 16 weeks ]

10.  Secondary:   Serum Soluble CD14 Levels at Baseline and 16 Weeks   [ Time Frame: baseline and 16 weeks ]

11.  Secondary:   Serum TNF-a Receptor 2 Levels at Baseline and 16 Weeks   [ Time Frame: baseline and 16 weeks ]

12.  Secondary:   Serum Hemoglobin A1c (HbA1c) Levels at Baseline and 16 Weeks   [ Time Frame: baseline and 16 weeks ]

13.  Secondary:   Serum Triglycerides Levels at Baseline and 16 Weeks   [ Time Frame: baseline and 16 weeks ]

14.  Secondary:   Serum Total Cholesterol Levels at Baseline and 16 Weeks   [ Time Frame: baseline and 16 weeks ]

15.  Secondary:   Serum HDL Cholesterol Levels at Baseline and 16 Weeks   [ Time Frame: baseline and 16 weeks ]

16.  Secondary:   Serum LDL Cholesterol Levels at Baseline and 16 Weeks   [ Time Frame: baseline and 16 weeks ]

17.  Secondary:   Body Weight at Baseline and 16 Weeks   [ Time Frame: baseline and 16 weeks ]

18.  Secondary:   Waist Circumference at Baseline and 16 Weeks   [ Time Frame: baseline and 16 weeks ]

19.  Secondary:   Hip Circumference at Baseline and 16 Weeks   [ Time Frame: baseline and 16 weeks ]

20.  Secondary:   Waist to Hip Ratio at Baseline and 16 Weeks   [ Time Frame: baseline and 16 weeks ]

21.  Other Pre-specified:   Peripheral Endothelial Tonography, as Measured by the Non-invasive EndoPAT System Using the LnRHI (Natural Log of Reactive Hyperemia Index), at Baseline and 16 Weeks   [ Time Frame: baseline and 16 weeks ]


  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
Trial terminated after only 6 individuals enrolled due to lack of interest in participation from patients and expiration of funding. Results are not considered reliable due to low number of observations


  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: John Koethe MD
Organization: Vanderbilt University Medical Center
phone: 615-343-0533
e-mail: john.r.koethe@vanderbilt.edu



Responsible Party: John R. Koethe, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01791465     History of Changes
Other Study ID Numbers: 121342
P30AI054999 ( U.S. NIH Grant/Contract )
First Submitted: February 11, 2013
First Posted: February 15, 2013
Results First Submitted: May 5, 2016
Results First Posted: March 10, 2017
Last Update Posted: March 10, 2017