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CompletedNCT02124681REHNISUpdated Jun 6, 2017

Rediscovering Hydroxychloroquine as a Novel Insulin Sensitizer

A Phase 1 interventional study of Hydroxychloroquine and Placebo in Insulin Resistance, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 21 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-06.

Sponsored by University of Pittsburgh · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
21 Years to 69 Years
Sex
All
01

Study summary

Current options to treat insulin resistance in diabetes are fairly limited. For this reason, novel treatments would represent a major progress. The generic drug hydroxychloroquine (HCQ) has poorly understood effects on blood sugar metabolism. In this study, the investigators will examine the mechanisms by which this drug affects glucose metabolism and which cells are affected. Findings emanating from this project will help establish whether HCQ may be a viable treatment for disorders of glucose metabolism.

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Conditions studied

  • Insulin Resistance

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03

In context

Insulin Resistance

1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.

This study's enrollment of 34 is below the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

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

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

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Who can participate

Ages eligible
21 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 21-69 years-old;
  • BMI 28-40;
  • Presence of at least one of the following markers of insulin resistance: a) fasting hyperinsulinemia (>7 uU/ml by ultrasensitive insulin assay); impaired fasting glucose (100-125 mg/dl); prior history of impaired glucose tolerance provided by the participant; history of previous gestational diabetes; history of PCOS; waist circumference >40" (men) or >35" (women) (cut-offs from ATP-III criteria for metabolic syndrome).

Exclusion criteria

Exclusion Criteria:

  • Pregnancy, or unable/unwilling to avoid pregnancy during the study;
  • Unstable cardiopulmonary disease, hepatitis, liver dysfunction, renal insufficiency, or any other medical condition affecting glucose metabolism or safety during the study;
  • Diabetes;
  • Medications that affect glucose metabolism: (e.g. systemic glucocorticoids, antipsychotics);
  • History of hypersensitivity to local lidocaine, similar anesthetics, or HCQ;
  • History of G6PDH deficiency;
  • History of retinopathy;
  • Weight instability (>3Kg of weight change in the past three months);
  • Bariatric surgery in the last two years, intention to lose weight or engage in exercise regimen during study;
  • Alcohol intake >1 drink/day (averaged);
  • Hemoglobin \<10g%
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
34 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo PO

    Other: Placebo

  • Experimental
    Hydroxychloroquine

    Hydroxychloroquine sulfate 400mg PO QD

    Drug: Hydroxychloroquine

Interventions

  • DrugHydroxychloroquine

    Hydroxychloroquine sulfate 400mg/d PO for 13±1 weeks

  • OtherPlacebo

    Placebo PO for 13±1 weeks

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What researchers measure

Primary outcomes

  1. Insulin sensitivity in muscle and liver

    Time frame: 13±1 weeks

Secondary outcomes

  1. biomarkers of inflammation

    Time frame: 13±1 weeks

07

Study locations

1 site
  • UPMC Montefiore Hospital
    Pittsburgh, Pennsylvania 15234, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02124681
Lead sponsor
University of Pittsburgh
Responsible party
Frederico Toledo (Associate Professor, University of Pittsburgh) — Principal investigator
First posted
Apr 28, 2014
Start date
Apr 2014
Primary completion
Aug 2016
Completion
Aug 2016
Last update
Jun 6, 2017

Study contacts

Frederico Toledo, MD
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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