Rediscovering Hydroxychloroquine as a Novel Insulin Sensitizer (REHNIS)

June 2, 2017 updated by: Frederico Toledo, University of Pittsburgh
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15234
        • UPMC Montefiore Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo PO
Other: Placebo
Placebo PO for 13±1 weeks
Experimental: Hydroxychloroquine
Hydroxychloroquine sulfate 400mg PO QD
Drug: Hydroxychloroquine
Hydroxychloroquine sulfate 400mg/d PO for 13±1 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Insulin sensitivity in muscle and liver
Time Frame: 13±1 weeks
13±1 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
biomarkers of inflammation
Time Frame: 13±1 weeks
13±1 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Frederico Toledo, MD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

April 24, 2014

First Submitted That Met QC Criteria

April 24, 2014

First Posted (Estimate)

April 28, 2014

Study Record Updates

Last Update Posted (Actual)

June 6, 2017

Last Update Submitted That Met QC Criteria

June 2, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO13060248

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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