Rediscovering Hydroxychloroquine as a Novel Insulin Sensitizer

Insulin Resistance Clinical Trial

— REHNIS  

Official title:

Rediscovering Hydroxychloroquine as a Novel Insulin Sensitizer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02124681
• Other study ID #: PRO13060248
• Status: Completed
• Phase: Phase 1
• First received: April 24, 2014
• Last updated: June 2, 2017
• Start date: April 2014
• Est. completion date: August 2016

Study information

• Verified date: June 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 69 Years

Eligibility

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%

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

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

Other:
• Placebo
Placebo PO for 13±1 weeks

Locations

Country	Name	City	State
United States	UPMC Montefiore Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity in muscle and liver		13±1 weeks
Secondary	biomarkers of inflammation		13±1 weeks