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DFMO for Type 1 Diabetes (TADPOL Trial)
TADPOL Trial Summary
This trial tests if a drug, DFMO, helps reduce stress on cells that make insulin and preserves insulin production in people with Type 1 Diabetes. Participants take DFMO/placebo 2x/day for 6 months & have 6 in-person & 1 phone visit over 12 months.
TADPOL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTADPOL Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TADPOL Trial Design
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Who is running the clinical trial?
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- I am not pregnant and agree to use two forms of birth control or remain abstinent.Your hearing test results must show that you can hear quiet sounds at different pitches.I am allergic to milk or soy.I am currently using anti-psychotic medication or have a psychiatric condition.You have abnormal blood test results, like low red or white blood cell counts.You have a mental health condition that would make it difficult for you to take part in the study.I do not have a severe illness affecting my eating or needing long-term medication, except for stable thyroid issues or mild asthma.I am between 6 and 40 years old and have been diagnosed with Type 1 Diabetes.I have not received any immune system modifying treatments.I am on medication for seizures or had a seizure in the last year.I was diagnosed with Type 1 Diabetes and started insulin within the last 100 days.My kidney function is not normal.I have a chronic illness or take medication that affects my blood sugar levels.I have tested positive for a diabetes-related autoantibody.Your C-peptide level is higher than a certain amount when you are not fasting.I cannot swallow pills.I have diabetes, but it's not Type 1.
- Group 1: Treatment Arm
- Group 2: Placebo Arm
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this research require enrollees to be older than 35 years old?
"The criteria for eligibility necessitates that those partaking in this study are aged between 6 and 40. Additionally, there are 219 medical trials available to minors, and 921 clinical trials catered towards senior citizens."
How many venues is this research project taking place within?
"Currently, 6 medical centres are running this trial. They include Kansas City, Indianapolis and Ann Arbor among others. To minimise travel time in the event of your enrolment, it is advised that you select the clinic closest to you."
What criteria must a person satisfy to be eligible for participation in this clinical trial?
"For admission into this clinical trial, prospective patients should have type 1 diabetes mellitus and be between the ages of 6 - 40. This study is currently looking to recruit around 70 qualified candidates."
What can be expected from the safety profile of Treatment Arm?
"There is some evidence to suggest that Treatment Arm can be considered safe, so it recieved a rating of 2 on the scale. This is due to this being a Phase 2 trial which has data suggesting safety but no information regarding efficacy."
Are there any available vacancies in this trial open to participants?
"The clinicaltrials.gov registry reveals that although this trial was first listed on December 1, 2022 and last modified on October 21, 2022, it no longer searches for participants. Fortunately, there are still 1258 other medical studies actively looking to enrol subjects at this time."
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