TArgeting Type 1 Diabetes Using POLyamines (TADPOL)

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Emily K. Sims
Study ID
NCT05594563
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
4 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • DFMO — DRUG
    DFMO orally twice a day
  • Placebo — DRUG
    Placebo orally twice a day

Study Details

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.

Key Dates

Start date
Mar 14, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
May 31, 2028

Study Design

Enrollment
81 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Treatment Arm
    Difluoromethylornithine (DFMO) pill ,1000mg/m2/day, for 6 months
  • Placebo Comparator: Placebo Arm
    Placebo pill taken twice a day orally for 6 months

Primary Outcome Measure

Clinical efficacy of 1000 mg/m2/day of oral DFMO after 6 months of treatment [ Time Frame: 6 month ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Barbara Davis CenterAuroraColorado80045
Lexie Chesshir, RN
[email protected]
303-724-1755
Kimber Simmons, MD (PRINCIPAL_INVESTIGATOR)
University of ChicagoChicagoIllinois60637
Cathleen Mulcahy, PhD,RN
[email protected]
773-702-9968
Siri Greeley, MD (PRINCIPAL_INVESTIGATOR)
IU Health Riley Hospital for ChildrenIndianapolisIndiana46202
Ellie M Moreau
[email protected]
317-278-7037
T1D Research
[email protected]
317-278-8879
Emily K Sims, MD, MS (PRINCIPAL_INVESTIGATOR)
Linda A DiMeglio, MD, MPH (SUB_INVESTIGATOR)
Children's Mercy HospitalKansas CityKansas64108
Morgan Rainey, RN
[email protected]
816-460-1097
Cintya Schweisberger, DO (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Aimee Katona
[email protected]
734-615-4079
Inas Thomas, MD (PRINCIPAL_INVESTIGATOR)
MHealth Fairview Masonic Children's Hospital and Specialty ClinicsMinneapolisMinnesota55454
Beth Pappenfus
[email protected]
612-624-6682
Brandon Nathan, MD (PRINCIPAL_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226
LaTonda Tyler
[email protected]
414-955-8486
Susanne Cabrera, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Barbara Davis Center· Aurora, COUniversity of Chicago· Chicago, ILIU Health Riley Hospital for Children· Indianapolis, INChildren's Mercy Hospital· Kansas City, KSUniversity of Michigan· Ann Arbor, MIMHealth Fairview Masonic Children's Hospital and Specialty Clinics· Minneapolis, MN

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