TArgeting Type 1 Diabetes Using POLyamines (TADPOL) (NCT05594563)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Barbara Davis Center โ Aurora, Colorado
Age range: 4 Years to 40 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (7 Sites)
- Barbara Davis Center โ Aurora, Colorado
- University of Chicago โ Chicago, Illinois
- IU Health Riley Hospital for Children โ Indianapolis, Indiana
- Children's Mercy Hospital โ Kansas City, Kansas
- University of Michigan โ Ann Arbor, Michigan
- MHealth Fairview Masonic Children's Hospital and Specialty Clinics โ Minneapolis, Minnesota
- Medical College of Wisconsin โ Milwaukee, Wisconsin
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Type 1 Diabetes
- A 12-week Pilot Nutrition Intervention for Children With New Diagnosis of Stage 3 Type 1 Diabetes (T1D) โ Hershey, Pennsylvania
- Remedy to Diabetes Distress (R2D2): A Scalable Screen to Treat Program for School-age Families โ Jacksonville, Florida
- Diabetes Inspired Culinary Education (DICE): Culinary Medicine Intervention for At-Risk Youth With Type 1 Diabetes โ Cleveland, Ohio
- GO TEAM: Glucose Optimization Through Technology Assisted Management โ Cleveland, Ohio
- REAL-Fam Feasibility Study for Youth Diabetes Management โ Chapel Hill, North Carolina
- Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes โ New York, New York
Explore by condition: All Type 1 Diabetes clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.