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

Completed · Phase 4 · Has a placebo group

Conditions studied: Pre-diabetes

In brief

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.

Key facts

Study ID

NCT01326533

Run by

University of Pittsburgh

People needed

32

Starts

2011-03-01

Expected to finish

2014-12-01

Last updated by the study team

2016-02-26

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > or = 18, able to provide informed consent
• Body-mass index greater than or equal to 25
• 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
• Negative pregnancy test for women with childbearing potential

You may not qualify if…

• Diagnosis of diabetes mellitus Type 1 or Type 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
• Oral corticosteroid use in prior six months, or expectation of needing corticosteroid therapy in upcoming six months
• Known allergy or intolerance to HCQ
• Known glucose-6 phosphate dehydrogenase deficiency
• Known eye disease associated with retinal pigmentation abnormalities
• Known diabetic retinopathy requiring past or planned laser therapy
• Inability to comply with visit schedule and protocol requirements
• Inability to manage and take medication as instructed
• Current or planned pregnancy in upcoming 12 months
• 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
• Anemia (HGB < 9)
• Any history of bariatric (weight loss) surgery
• Current use of the medication Glucophage (metformin)
• Weight changes of 6 pounds or more in the past 4 weeks
• 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

Where it is running

• University of Pittsburgh, Montefiore Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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