Reducing Risk of Type 2 Diabetes: Hydroxychloroquine Use in Pre-Diabetes

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Frederico Toledo, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01326533
First received: March 29, 2011
Last updated: December 22, 2015
Last verified: December 2015
Results First Received: December 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Basic Science
Condition: Pre-diabetes
Interventions: Drug: hydroxychloroquine
Other: Placebo

  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
Hydroxychloroquine 13 weeks of hydroxychloroquine sulfate PO 400 mg/day
Placebo 13 weeks of placebo PO

Participant Flow:   Overall Study
    Hydroxychloroquine     Placebo  
STARTED     17     15  
COMPLETED     13     15  
NOT COMPLETED     4     0  
Lost to Follow-up                 2                 0  
Withdrawal by Subject                 1                 0  
Adverse Event                 1                 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
Hydroxychloroquine Hydroxychloroquine sulfate PO 400 mg daily
Placebo Placebo daily
Total Total of all reporting groups

Baseline Measures
    Hydroxychloroquine     Placebo     Total  
Number of Participants  
[units: participants]
  17     15     32  
Age  
[units: years]
Mean (Standard Deviation)
  50.1  (14.5)     44.9  (16.8)     47.6  (15.7)  
Gender  
[units: participants]
     
Female     15     9     24  
Male     2     6     8  
Insulin sensitivity (Si)  
[units: 10^-4 / pmol.l / min]
Mean (Standard Deviation)
  0.52  (0.27)     0.58  (0.42)     0.55  (0.34)  
Beta cell function (disposition index)  
[units: arbitrary units]
Mean (Standard Deviation)
  1721  (2014)     1214  (691)     1483  (1540)  



  Outcome Measures
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1.  Primary:   Insulin Sensitivity   [ Time Frame: 13 weeks after baseline measurement ]

2.  Secondary:   Beta Cell Function   [ Time Frame: 13 weeks after baseline measurement ]


  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: Frederico Toledo
Organization: University of Pittsburgh
phone: 412-692-2848
e-mail: .toledofs@upmc.edu


No publications provided by University of Pittsburgh

Publications automatically indexed to this study:

Responsible Party: Frederico Toledo, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01326533     History of Changes
Other Study ID Numbers: DK082878
5R21DK082878-02 ( US NIH Grant/Contract Award Number )
Study First Received: March 29, 2011
Results First Received: December 22, 2015
Last Updated: December 22, 2015
Health Authority: United States: Institutional Review Board