Last updated on August 2019

Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus


Brief description of study

The study is a 2-arm, double blinded, multicenter, 2:1 randomized, placebo controlled clinical trial. Subjects will receive hydroxychloroquine or placebo and close monitoring for progression of T1D.

Detailed Study Description

This study is testing a medication, called hydroxychloroquine (HCQ) to assess safety and effectiveness to prevent individuals at risk of type 1 diabetes (T1D) from progressing to type 1 diabetes.

HCQ is approved by the U.S. Food and Drug Administration as a treatment for malaria, lupus, and rheumatoid arthritis. HCQ has been used extensively for treatment of autoimmune disease in adults, children, and during pregnancy. This medication has not previously been studied as a treatment to prevent T1D.

The goal of this study is to learn if HCQ can help prevent or delay progression from normal glucose tolerance (Stage 1) to abnormal glucose tolerance (Stage 2) or type 1 diabetes (Stage 3).

The study involves 5 visits in the first 6 months, then 1 visit every 6 months for the remainder of the study.

Clinical Study Identifier: NCT03428945

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University of Pittsburgh

Pittsburgh, PA United States
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Benaroya Research Institute

Seattle, WA United States
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Barbara Davis Center

Aurora, CO United States
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Children's Hospital Los Angeles

Los Angeles, CA United States
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Stanford University

Stanford, CA United States
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University of Florida

Gainesville, FL United States
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University of Miami

Miami, FL United States
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USF Diabetes Center

Tampa, FL United States
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Emory Children's Center

Atlanta, GA United States
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University of Chicago

Chicago, IL United States
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University of Iowa

Iowa City, IA United States
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Joslin Diabetes Center

Boston, MA United States
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University of Minnesota

Minneapolis, MN United States
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The Children's Mercy Hospital

Kansas City, MO United States
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Palm Research Center, Inc.

Las Vegas, NV United States
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UBMD Pediatrics

Buffalo, NY United States
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Columbia University

New York, NY United States
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The University of Oklahoma

Oklahoma City, OK United States
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Childrens Hospital of Philadelphia

Philadelphia, PA United States
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GHS - Pediatric Endocrinology

Greenville, SC United States
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University of Utah

Salt Lake City, UT United States
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University of Bristol

Bristol, United Kingdom
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