RecruitingPhase 2NCT05594563

TArgeting Type 1 Diabetes Using POLyamines (TADPOL)

TArgeting Type 1 Diabetes Using POLyamines (TADPOL): A Randomized, Double-Masked, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of Difluoromethylornithine (DFMO) to Preserve Insulin Production in Type 1 Diabetes


Sponsor

Emily K. Sims

Enrollment

81 participants

Start Date

Mar 14, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to test a drug known as DFMO in people with Type 1 Diabetes (T1D). The main question\[s\] it aims to answer are: * Does it reduce stress on the cells that make insulin? * Does it preserve what is left of the body's insulin production? Participants will take either DFMO or a placebo (looks like DFMO but has no active ingredients) two times a day for about 6 months. Participants will have 6 in person visits and 1 phone visit over a period of 12 months. Visits will include blood draws urine collection and other tests.


Eligibility

Min Age: 4 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether naturally occurring compounds called polyamines can help preserve insulin production in people newly diagnosed with type 1 diabetes. In type 1 diabetes, the immune system destroys the cells that make insulin; polyamines may help slow this process. **You may be eligible if...** - You are 4 years of age or older and have been clinically diagnosed with type 1 diabetes - Your diabetes diagnosis was made no more than 100 days ago - You still have some remaining insulin production (confirmed by a C-peptide blood test) - You tested positive for at least one diabetes-related autoantibody - You have not previously taken any immune-modifying medication - You have normal hearing **You may NOT be eligible if...** - You have another type of diabetes (not type 1) - You have a serious chronic illness that affects eating or requires long-term medication (with some exceptions) - You have a psychiatric disorder affecting study participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDFMO

DFMO orally twice a day

DRUGPlacebo

Placebo orally twice a day


Locations(7)

Barbara Davis Center

Aurora, Colorado, United States

University of Chicago

Chicago, Illinois, United States

IU Health Riley Hospital for Children

Indianapolis, Indiana, United States

Children's Mercy Hospital

Kansas City, Kansas, United States

University of Michigan

Ann Arbor, Michigan, United States

MHealth Fairview Masonic Children's Hospital and Specialty Clinics

Minneapolis, Minnesota, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT05594563


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