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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Frederico Toledo, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01326533
First received: March 29, 2011
Last updated: June 11, 2015
Last verified: June 2015

March 29, 2011
June 11, 2015
March 2011
March 2013   (final data collection date for primary outcome measure)
Insulin sensitivity [ Time Frame: Frequently sampled intravenous glucose tolerance testing (FSIGTT) at baseline and 3 months ] [ Designated as safety issue: No ]
Glucose metabolism, regulated by insulin secretion and sensitivity, as measured by FSIGTT, will improve in subjects with pre-diabetes treated with hydroxychloroquine compared with placebo for approximately 13 weeks.
Same as current
Complete list of historical versions of study NCT01326533 on ClinicalTrials.gov Archive Site
Beta cell function [ Time Frame: Frequently sampled intravenous glucose tolerance testing (FSIGTT) at baseline and 3 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Reducing Risk of Type 2 Diabetes: Hydroxychloroquine Use in Pre-Diabetes
Mechanisms of Action of Hydroxychloroquine in Reducing Risk of Type 2 Diabetes

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Pre-diabetes
  • Drug: hydroxychloroquine
    Thirteen weeks 400 mg oral hydroxychloroquine capsule taken after frequently sampled intravenous glucose tolerance testing (FSIGTT)
    Other Name: Plaquenil
  • Other: Sugar pill
    Thirteen weeks oral inert substance taken in capsule daily
    Other Name: microcellulose
  • Experimental: hydroxychloroquine
    Thirteen weeks of daily hydroxychloroquine therapy following FSIGTT testing
    Intervention: Drug: hydroxychloroquine
  • Placebo Comparator: Sugar pill
    Thirteen weeks of daily sugar pill following FSIGTT testing
    Intervention: Other: Sugar pill
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
December 2014
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01326533
DK082878, 5R21DK082878-02
Yes
Frederico Toledo, University of Pittsburgh
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Frederico Toledo, MD University of Pittsburgh
University of Pittsburgh
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP