RECRUITING

TArgeting Type 1 Diabetes Using POLyamines (TADPOL)

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03-14

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05594563

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Years to 40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
1. Males and females 4- ≥40 years of age with a clinical diagnosis of T1D 2. T1D clinical diagnosis with insulin start date no more than 100 days prior to the time of randomization 3. Random non-fasting C-peptide level of \>0.2 pmol/mL (equivalent to \>0.6ng/ml) at screening. 4. Positive for any one of the following diabetes-related autoantibodies (IAA, GAA, IA-2, or ZnT8) 5. Treatment naïve of any immunomodulatory agent 6. Normal hearing at screening, defined as acceptable results of pure-tone audiometry (\<20 decibel \[dB\] baseline thresholds for frequencies 250, 500, 1000, and 2000 Hz	1. Presence of severe, active disease that interferes with dietary intake or requires the use of chronic medication, with the exception of well-controlled hypothyroidism and mild asthma not requiring oral steroids. Presence of any psychiatric disorder that will affect ability to participate in study. 2. Diabetes other than T1D 3. Chronic illness known to affect glucose metabolism (e.g. Cushing syndrome, polycystic ovarian disorder, cystic fibrosis) or taking medications that affect glucose metabolism (e.g. steroids, metformin) 4. Inability to swallow pills 5. Psychiatric impairment or current use of anti-psychotic medication 6. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results. 7. Neutropenia (\< 1,500 neutrophils/μL) 8. Leukopenia (\< 3,000 leukocytes /μL) 9. Lymphopenia ( \< 800 lymphocytes/μL) 10. Thrombocytopenia (\<100,000 platelets/μL) 11. Clinically significant anemia or Hemoglobin as defined below: 12. Impaired renal function (assessed by history and BUN/Creatinine, DFMO is renally excreted) 13. Allergy to milk or soy (components of Boost® drink used for mixed meal tolerance testing) 14. Female participants of child-bearing age with reproductive potential, must not be pregnant and agree to use 2 effective forms of birth control or be abstinent during the study period (see below). Male participants (including men who have had vasectomies) whose partners are pregnant or may be pregnant should use condoms while on study drug, until 2 weeks after discontinuation of drug, while the partner is pregnant. 15. Active seizure disorder, defined as requiring chronic medication at the time of study or having had a seizure within the past 12 months at the time of screening 16. Enrollment into another intervention trial.

Inclusion Criteria

Exclusion Criteria

1. Males and females 4- ≥40 years of age with a clinical diagnosis of T1D
2. T1D clinical diagnosis with insulin start date no more than 100 days prior to the time of randomization
3. Random non-fasting C-peptide level of \>0.2 pmol/mL (equivalent to \>0.6ng/ml) at screening.
4. Positive for any one of the following diabetes-related autoantibodies (IAA, GAA, IA-2, or ZnT8)
5. Treatment naïve of any immunomodulatory agent
6. Normal hearing at screening, defined as acceptable results of pure-tone audiometry (\<20 decibel \[dB\] baseline thresholds for frequencies 250, 500, 1000, and 2000 Hz

1. Presence of severe, active disease that interferes with dietary intake or requires the use of chronic medication, with the exception of well-controlled hypothyroidism and mild asthma not requiring oral steroids. Presence of any psychiatric disorder that will affect ability to participate in study.
2. Diabetes other than T1D
3. Chronic illness known to affect glucose metabolism (e.g. Cushing syndrome, polycystic ovarian disorder, cystic fibrosis) or taking medications that affect glucose metabolism (e.g. steroids, metformin)
4. Inability to swallow pills
5. Psychiatric impairment or current use of anti-psychotic medication
6. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results.
7. Neutropenia (\< 1,500 neutrophils/μL)
8. Leukopenia (\< 3,000 leukocytes /μL)
9. Lymphopenia ( \< 800 lymphocytes/μL)
10. Thrombocytopenia (\<100,000 platelets/μL)
11. Clinically significant anemia or Hemoglobin as defined below:
12. Impaired renal function (assessed by history and BUN/Creatinine, DFMO is renally excreted)
13. Allergy to milk or soy (components of Boost® drink used for mixed meal tolerance testing)
14. Female participants of child-bearing age with reproductive potential, must not be pregnant and agree to use 2 effective forms of birth control or be abstinent during the study period (see below). Male participants (including men who have had vasectomies) whose partners are pregnant or may be pregnant should use condoms while on study drug, until 2 weeks after discontinuation of drug, while the partner is pregnant.
15. Active seizure disorder, defined as requiring chronic medication at the time of study or having had a seizure within the past 12 months at the time of screening
16. Enrollment into another intervention trial.

Contacts and Locations

Study Contact

Maria L Spall, BSN

CONTACT

317-278-7034

malnicho@iu.edu

Operations Manager

CONTACT

317-278-8879

tadpol@iu.edu

Principal Investigator

Emily K Sims, MD,MS

STUDY_CHAIR

Indiana University School of Medicine

Study Locations (Sites)

Barbara Davis Center

Aurora, Colorado, 80045

United States

University of Chicago

Chicago, Illinois, 60637

United States

IU Health Riley Hospital for Children

Indianapolis, Indiana, 46202

United States

Children's Mercy Hospital

Kansas City, Kansas, 64108

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Emily K. Sims

Emily K Sims, MD,MS, STUDY_CHAIR, Indiana University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-14

Study Completion Date2027-12

Study Record Updates

Study Start Date2023-03-14

Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

Type 1 Diabetes