Rediscovering Hydroxychloroquine as a Novel Insulin Sensitizer

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02124681

Acronym

REHNIS

Enrollment

Registered

2014-04-28

Start date

2014-04-30

Completion date

2016-08-31

Last updated

2017-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance

Brief 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.

Interventions

DRUGHydroxychloroquine

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

OTHERPlacebo

Placebo PO for 13±1 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 69 Years

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

* 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%

Design outcomes

Primary

Measure	Time frame
Insulin sensitivity in muscle and liver	13±1 weeks

Secondary

Measure	Time frame
biomarkers of inflammation	13±1 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026