Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus (TN20)



Status:Active, not recruiting
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:3 - 45
Updated:1/10/2018
Start Date:January 2016
End Date:March 2018

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Exploring Immunologic Effects of Oral Insulin in Relatives at Risk for Type 1

The study is a 2 arm, multi-center, randomized, open-labeled clinical trial designed to
assess the effects of varying doses and schedules of oral insulin on immunological and
metabolic markers in relatives at risk for type 1 diabetes (T1D).

A minimum of 40 eligible participants will be identified for study participation from the
TrialNet Pathway to Prevention study. Participants must have a relative with type 1 diabetes
and be positive for insulin autoantibodies and at least one other autoantibody. All
participants will receive active treatment of recombinant insulin treatment in capsules of
either 67.5 mg daily or 500mg every other week. Participants will need to visit the study
site up to eleven times over one year for blood tests and other study procedures. During the
beginning treatment phase there are two visits one month apart for those given the 67.5 mg
dose, and three visits two weeks apart to titrate the dose for those in the 500mg treatment
group. There are three additional treatment visits at months 2, 3, and 6 and 4 additional
visits for follow-up at months 7, 8, 9 and 12. The primary outcome is the change in immune
function as assessed by change in level or quality of T lymphocyte or autoantibody biomarkers
measured between 13 and 26 weeks compared to baseline. .

Inclusion Criteria:

- Participants in TrialNet Natural History/Pathway to Prevention Study (TN01); is
relative of proband with type 1 diabetes

- Between ages 3-45 with normal Oral Glucose Tolerance Test (OGTT) or between ages 3-7
with an abnormal OGTT

- Confirmed positive for insulin autoantibodies within previous six months

- Confirmed positive for one or more other autoantibodies on two separate occasions
within the past six months

Exclusion Criteria:

- Diagnosed with type 1 diabetes

- History of treatment with insulin or oral hypoglycemic agent

- History of therapy with immunosuppressive drugs or non-physiologic glucocorticoids
within the past two years for a period of more than three months

- Ongoing use of medications known to influence glucose tolerance

- Pregnant or intending to become pregnant while on study or lactating
We found this trial at
17
sites
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Maria Rendondo, MD
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Louis Philipson, MD
Phone: 773-702-3853
University of Chicago One of the world's premier academic and research institutions, the University of...
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Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Desmond Schatz, MD
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Jennifer Marks, MD
Phone: 305-243-3781
University of Miami A private research university with more than 15,000 students from around the...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: Dorothy Becker, MBBCh
Phone: 412-692-5210
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Principal Investigator: Henry Rodriguez, MD
Phone: 813-396-9574
University of South Florida The University of South Florida is a high-impact, global research university...
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Atlanta, Georgia 30322
Principal Investigator: Andrew Muir, MD
Phone: 404-727-1098
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Atlanta, GA
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Aurora, Colorado 80010
Principal Investigator: Andrea Steck, MD
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One Joslin Place
Boston, Massachusetts 02215
617-309-2400
Principal Investigator: Jason Gaglia, MD
Phone: 888-813-8669
Joslin Diabetes Center Joslin Diabetes Center, located in Boston, Massachusetts, is the world's largest diabetes...
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Dallas, Texas 75390
Principal Investigator: Philip Raskin, MD
Phone: 214-648-4717
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Indianapolis, Indiana 46202
Principal Investigator: Linda DiMeglio, MD
Phone: 866-230-8486
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Principal Investigator: William Russell, MD
Phone: 615-936-8638
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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New York, New York
Principal Investigator: Robin Goland, MD
Phone: 212-851-5425
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Parkville, Victoria
Principal Investigator: John Wentworth, MD
Phone: 9342 7063
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San Francisco, California 94143
Principal Investigator: Stephen Gitelman, MD
Phone: 415-476-5026
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Seattle, Washington 98101
Principal Investigator: Carla Greenbaum, MD
Phone: 206-515-5239
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Darrell Wilson, MD
Phone: 650-498-4450
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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