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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

Brief Summary:
The purpose of this study is to determine the short-term effects of the antimalarial medication, hydroxychloroquine (HCQ), compared with placebo using frequently sampled intravenous glucose tolerance testing (FSIGTT) methodology to study changes in insulin secretion and glucose tolerance in subjects at risk for developing Type 2 diabetes.

Condition or disease Intervention/treatment Phase
Pre-diabetes Drug: hydroxychloroquine Other: Placebo Phase 4

Detailed Description:
Diabetes is approaching epidemic proportions in the United States. This study evaluates the mechanisms of action of a generic drug that may have effects on glucose metabolism.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Mechanisms of Action of Hydroxychloroquine in Reducing Risk of Type 2 Diabetes
Study Start Date : March 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
Experimental: hydroxychloroquine
Thirteen weeks of daily hydroxychloroquine following FSIGTT testing
Drug: hydroxychloroquine
Thirteen weeks of oral hydroxychloroquine (400 mg/day) provided as capsules
Other Name: Plaquenil

Placebo Comparator: Placebo
Thirteen weeks of daily placebo following FSIGTT testing
Other: Placebo
Thirteen weeks of oral placebo provided as capsules
Other Name: microcellulose placebo

Primary Outcome Measures :
  1. Insulin Sensitivity [ Time Frame: 13 weeks after baseline measurement ]
    Change from baseline in the insulin sensitivity index (Si)

Secondary Outcome Measures :
  1. Beta Cell Function [ Time Frame: 13 weeks after baseline measurement ]
    Change from baseline in the disposition index (DI)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age > or = 18, able to provide informed consent
  2. Body-mass index greater than or equal to 25
  3. Presence of at least one indicator of insulin resistance from the following list:

    • Family history of Type 2 diabetes (parent, sibling)
    • Fasting glucose 100 - 125 mg/dl
    • Fasting serum insulin greater than or equal to 7uU/ml
    • Personal history of gestational diabetes
  4. Negative pregnancy test for women with childbearing potential

Exclusion Criteria:

  1. Diagnosis of diabetes mellitus Type 1 or Type 2
  2. Active autoimmune disease, chronic infection, current malignancy (excluding basal cell carcinoma), or other active inflammatory state that, in the opinion of the investigators, would affect insulin sensitivity
  3. Oral corticosteroid use in prior six months, or expectation of needing corticosteroid therapy in upcoming six months
  4. Known allergy or intolerance to HCQ
  5. Known glucose-6 phosphate dehydrogenase deficiency
  6. Known eye disease associated with retinal pigmentation abnormalities
  7. Known diabetic retinopathy requiring past or planned laser therapy
  8. Inability to comply with visit schedule and protocol requirements
  9. Inability to manage and take medication as instructed
  10. Current or planned pregnancy in upcoming 12 months
  11. Inability or unwillingness to use reliable method of contraception (for women of childbearing years, men, or men's partners with childbearing potential), such as oral contraceptive pills, barrier method (diaphragm and condom with spermicide), intrauterine device, or depo-provera injections for 3 months prior to enrollment
  12. Anemia (HGB < 9)
  13. Any history of bariatric (weight loss) surgery
  14. Current use of the medication Glucophage (metformin)
  15. Weight changes of 6 pounds or more in the past 4 weeks
  16. Any other underlying or concomitant condition, which in the opinion of the principal investigator, could confound the results of the study or put the subject at undue risk

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01326533

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United States, Pennsylvania
University of Pittsburgh, Montefiore Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Frederico Toledo, MD University of Pittsburgh
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Frederico Toledo, Principal Investigator, University of Pittsburgh Identifier: NCT01326533    
Other Study ID Numbers: DK082878
5R21DK082878-02 ( U.S. NIH Grant/Contract )
First Posted: March 31, 2011    Key Record Dates
Results First Posted: January 29, 2016
Last Update Posted: February 26, 2016
Last Verified: January 2016
Keywords provided by Frederico Toledo, University of Pittsburgh:
frequently sampled intravenous glucose tolerance testing
insulin resistance
insulin secretion
glucose tolerance
Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents