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

This study has been completed.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Frederico Toledo, University of Pittsburgh Identifier:
First received: March 29, 2011
Last updated: January 28, 2016
Last verified: January 2016
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 Intervention Phase
Drug: hydroxychloroquine
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Mechanisms of Action of Hydroxychloroquine in Reducing Risk of Type 2 Diabetes

Resource links provided by NLM:

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Insulin Sensitivity [ Time Frame: 13 weeks after baseline measurement ] [ Designated as safety issue: No ]
    Change from baseline in the insulin sensitivity index (Si)

Secondary Outcome Measures:
  • Beta Cell Function [ Time Frame: 13 weeks after baseline measurement ] [ Designated as safety issue: No ]
    Change from baseline in the disposition index (DI)

Enrollment: 32
Study Start Date: March 2011
Study Completion Date: December 2014
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT01326533

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)
Principal Investigator: Frederico Toledo, MD University of Pittsburgh
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Frederico Toledo, Principal Investigator, University of Pittsburgh Identifier: NCT01326533     History of Changes
Other Study ID Numbers: DK082878  5R21DK082878-02 
Study First Received: March 29, 2011
Results First Received: December 22, 2015
Last Updated: January 28, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
frequently sampled intravenous glucose tolerance testing
insulin resistance
insulin secretion
glucose tolerance

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Intolerance
Prediabetic State
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Antirheumatic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 26, 2016