Actively Recruiting
TArgeting Type 1 Diabetes Using POLyamines (TADPOL)
Led by Emily K. Sims · Updated on 2026-04-20
81
Participants Needed
7
Research Sites
267 weeks
Total Duration
On this page
Sponsors
E
Emily K. Sims
Lead Sponsor
J
Juvenile Diabetes Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
TArgeting Type 1 Diabetes Using POLyamines (TADPOL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females 4- 60 years of age with a clinical diagnosis of T1D
- T1D clinical diagnosis with insulin start date no more than 100 days prior to randomization
- Random non-fasting C-peptide level of >0.2 pmol/mL at screening
- Positive for at least one diabetes-related autoantibody (IAA, GAA, IA-2, or ZnT8)
- No prior treatment with any immunomodulatory agents
- Normal hearing confirmed by pure-tone audiometry (<20 decibel thresholds for all tested frequencies)
You will not qualify if you...
- Severe, active disease interfering with diet or requiring chronic medication, except well-controlled hypothyroidism and mild asthma not needing oral steroids
- Psychiatric disorders affecting participation
- Diabetes other than T1D
- Chronic illnesses affecting glucose metabolism or use of medications like steroids or metformin
- Inability to swallow pills
- Current psychiatric impairment or use of antipsychotic medication
- Any condition that may compromise study participation or affect study results
- Low neutrophil count (<1,500 neutrophils/bcL)
- Low leukocyte count (<3,000 leukocytes/bcL)
- Low lymphocyte count (<800 lymphocytes/bcL)
- Low platelet count (<100,000 platelets/bcL)
- Clinically significant anemia or low hemoglobin levels as defined for adults and children
- Impaired kidney function
- Allergy to milk or soy (components of Boost�AE drink)
- Females of childbearing potential must not be pregnant and must use two forms of birth control or be abstinent
- Male participants with pregnant partners must use condoms during and for two weeks after study drug use
- Active seizure disorder requiring chronic medication or seizure within past 12 months
- Participation in another intervention trial
- Use of automated insulin delivery systems that do not allow manual insulin suspension or modification
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Barbara Davis Center
Aurora, Colorado, United States, 80045
Actively Recruiting
2
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
3
IU Health Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
4
Children's Mercy Hospital
Kansas City, Kansas, United States, 64108
Actively Recruiting
5
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
6
MHealth Fairview Masonic Children's Hospital and Specialty Clinics
Minneapolis, Minnesota, United States, 55454
Actively Recruiting
7
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
M
Maria L Spall, BSN
CONTACT
O
Operations Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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