Back to resultsRediscovering Hydroxychloroquine as a Novel Insulin Sensitizer (REHNIS)
Primary Purpose
Insulin Resistance
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hydroxychloroquine
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Insulin Resistance
Eligibility Criteria
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%
Sites / Locations
- UPMC Montefiore Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Hydroxychloroquine
Arm Description
Placebo PO
Hydroxychloroquine sulfate 400mg PO QD
Outcomes
Primary Outcome Measures
Insulin sensitivity in muscle and liver
Secondary Outcome Measures
biomarkers of inflammation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02124681
Brief Title
Rediscovering Hydroxychloroquine as a Novel Insulin Sensitizer
Acronym
REHNIS
Official Title
Rediscovering Hydroxychloroquine as a Novel Insulin Sensitizer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo PO
Arm Title
Hydroxychloroquine
Arm Type
Experimental
Arm Description
Hydroxychloroquine sulfate 400mg PO QD
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
Hydroxychloroquine sulfate 400mg/d PO for 13±1 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo PO for 13±1 weeks
Primary Outcome Measure Information:
Title
Insulin sensitivity in muscle and liver
Time Frame
13±1 weeks
Secondary Outcome Measure Information:
Title
biomarkers of inflammation
Time Frame
13±1 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederico Toledo, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Montefiore Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15234
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Rediscovering Hydroxychloroquine as a Novel Insulin Sensitizer
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