Reducing Risk of Type 2 Diabetes: Hydroxychloroquine Use in Pre-Diabetes
Condition: Pre-diabetes
MeSH terms: Diabetes Mellitus; Prediabetic State; Glucose Intolerance
Intervention: hydroxychloroquine; Placebo
Intervention description: Thirteen weeks of oral hydroxychloroquine (400 mg/day) provided as capsules; Thirteen weeks of oral placebo provided as capsules
Intervention MeSH terms: Hydroxychloroquine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: pre-diabetes; hydroxychloroquine; frequently sampled intravenous glucose tolerance testing; insulin resistance; insulin secretion; glucose tolerance

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.
    

Eligibility criteria:

        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