Rediscovering Hydroxychloroquine as a Novel Insulin Sensitizer

NCT02124681 | Completed Phase 1

• 1 other identifier: PRO13060248
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity in muscle and liver

  13±1 weeks

Secondary Outcomes (1)

• biomarkers of inflammation

  13±1 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo PO

Other: Placebo

Hydroxychloroquine

EXPERIMENTAL

Hydroxychloroquine sulfate 400mg PO QD

Drug: Hydroxychloroquine

Interventions

Hydroxychloroquine DRUG

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

Hydroxychloroquine

Placebo OTHER

Placebo PO for 13±1 weeks

Placebo

Eligibility Criteria

• Age: 21 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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%

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Montefiore Hospital

Pittsburgh, Pennsylvania, 15234, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Frederico Toledo, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 28, 2014
• Study Start: April 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: June 6, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)