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

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. Identifier: NCT01326533
Recruitment Status : Completed
First Posted : March 31, 2011
Results First Posted : January 29, 2016
Last Update Posted : February 26, 2016
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Frederico Toledo, University of Pittsburgh

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition: Pre-diabetes
Interventions: Drug: hydroxychloroquine
Other: Placebo

  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
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 
Lost to Follow-up                2                0 
Withdrawal by Subject                1                0 
Adverse Event                1                0 

  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.
No text entered.

Reporting Groups
Hydroxychloroquine Hydroxychloroquine sulfate PO 400 mg daily
Placebo Placebo daily
Total Total of all reporting groups

Baseline Measures
   Hydroxychloroquine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   15   32 
[Units: Years]
Mean (Standard Deviation)
 50.1  (14.5)   44.9  (16.8)   47.6  (15.7) 
[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

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

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
No text entered.

  More Information

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

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Frederico Toledo, University of Pittsburgh Identifier: NCT01326533     History of Changes
Other Study ID Numbers: DK082878
5R21DK082878-02 ( U.S. NIH Grant/Contract )
First Submitted: March 29, 2011
First Posted: March 31, 2011
Results First Submitted: December 22, 2015
Results First Posted: January 29, 2016
Last Update Posted: February 26, 2016