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CompletedNCT01326533Updated Feb 26, 2016Results posted

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

A Phase 4 interventional study of hydroxychloroquine and Placebo in Pre-diabetes, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-02-26.

Sponsored by University of Pittsburgh · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pre-diabetes

Keywords

  • pre-diabetes
  • hydroxychloroquine
  • frequently sampled intravenous glucose tolerance testing
  • insulin resistance
  • insulin secretion
  • glucose tolerance
03

In context

Glucose Intolerance

792 studies on the registry are indexed under Glucose Intolerance; 126 are open to participants now.

This study's enrollment of 32 is below the median of 60 across 656 interventional studies indexed under Glucose Intolerance.

Browse Glucose Intolerance studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,414 studies on the registry; 168 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Browse University of Pittsburgh studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    hydroxychloroquine

    Thirteen weeks of daily hydroxychloroquine following FSIGTT testing

    Drug: hydroxychloroquine

  • Placebo comparator
    Placebo

    Thirteen weeks of daily placebo following FSIGTT testing

    Other: Placebo

Interventions

  • Drughydroxychloroquine

    Thirteen weeks of oral hydroxychloroquine (400 mg/day) provided as capsules

    Also known as: Plaquenil

  • OtherPlacebo

    Thirteen weeks of oral placebo provided as capsules

    Also known as: microcellulose placebo

06

What researchers measure

Primary outcomes

  1. Insulin Sensitivity

    Change from baseline in the insulin sensitivity index (Si)

    Time frame: 13 weeks after baseline measurement

Secondary outcomes

  1. Beta Cell Function

    Change from baseline in the disposition index (DI)

    Time frame: 13 weeks after baseline measurement

07

Results

Posted Jan 29, 2016

Participant flow

Participant flow — Overall Study
MilestoneHydroxychloroquinePlacebo
Started1715
Completed1315
Not completed40
Withdrew: Lost to follow-up20
Withdrew: Withdrawal by subject10
Withdrew: Adverse event10

Outcome measures

PrimaryInsulin Sensitivity

Change from baseline in the insulin sensitivity index (Si)

Time frame:
13 weeks after baseline measurement
Reported as:
Mean · 10^-4/pmol*l/min
Insulin Sensitivity
10^-4/pmol*l/minHydroxychloroquinePlacebo
Insulin Sensitivity0.08 ± 0.03-0.11 ± 0.04
Statistical analysis
  • Hydroxychloroquine vs Placebo · ANCOVA · p = <0.01Adjusted for baseline value as covariate
SecondaryBeta Cell Function

Change from baseline in the disposition index (DI)

Time frame:
13 weeks after baseline measurement
Reported as:
Mean · arbitrary units
Beta Cell Function
arbitrary unitsHydroxychloroquinePlacebo
Beta Cell Function352 ± 143-218 ± 158
Statistical analysis
  • Hydroxychloroquine vs Placebo · ANCOVA · p = 0.013Adjusted for baseline value as covariate

Adverse events

Collected over During 13 weeks of treatment. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Hydroxychloroquine—0/17 (0%)3/17 (17.6%)
Placebo—0/15 (0%)3/15 (20%)
Most frequent other events
Most frequent other events
EventHydroxychloroquinePlacebo
Dyspepsia or GI discomfortGastrointestinal disorders3/173/15
Unusual or vivid dreamsGeneral disorders2/171/15
HeadacheGeneral disorders2/170/15

Baseline characteristics

Age, Continuous
Age, Continuous(years)HydroxychloroquinePlaceboTotal
Mean50.1 ± 14.544.9 ± 16.847.6 ± 15.7
Sex: Female, Male
Sex: Female, Male(Participants)HydroxychloroquinePlaceboTotal
Female15924
Male268
Insulin sensitivity (Si)
Insulin sensitivity (Si)(10^-4 / pmol*l / min)HydroxychloroquinePlaceboTotal
Mean0.52 ± 0.270.58 ± 0.420.55 ± 0.34
Beta cell function (disposition index)
Beta cell function (disposition index)(arbitrary units)HydroxychloroquinePlaceboTotal
Mean1721 ± 20141214 ± 6911483 ± 1540
08

Study locations

1 site
  • University of Pittsburgh, Montefiore Hospital
    Pittsburgh, Pennsylvania 15213, United States
09

References and documents

Publications

  • Wasko MC, McClure CK, Kelsey SF, Huber K, Orchard T, Toledo FG. Antidiabetogenic effects of hydroxychloroquine on insulin sensitivity and beta cell function: a randomised trial. Diabetologia. 2015 Oct;58(10):2336-43. doi: 10.1007/s00125-015-3689-2. Epub 2015 Jul 22. PubMed 26197707 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01326533
Lead sponsor
University of Pittsburgh
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Frederico Toledo (Principal Investigator, University of Pittsburgh) — Principal investigator
First posted
Mar 31, 2011
Start date
Mar 2011
Primary completion
Mar 2013
Completion
Dec 2014
Results posted
Jan 29, 2016
Last update
Feb 26, 2016

Study contacts

Frederico Toledo, MD
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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