Phase 4
Completed N=32
Reducing Risk of Type 2 Diabetes: Hydroxychloroquine Use in Pre-Diabetes
Pre-diabetes
Source: ClinicalTrials.gov NCT01326533 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcomePrimary: Insulin Sensitivity — 0.08; -0.11 10^-4/pmol*l/min — p=<0.01
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insulin Sensitivity |
0.08; -0.11 | <0.01 sig |
| SECONDARY Beta Cell Function |
352; -218 | 0.013 sig |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01326533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.