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Islet + Parathyroid Co-transplant for Type 1 Diabetes (PARADIGM Trial)
PARADIGM Trial Summary
This trial is testing whether it is safe to transplant pancreatic islets along with another organ from the same donor, in people with Type 1 diabetes who have already had a kidney and/or liver transplant. The goal is to see if the islets will engraft and the person will become insulin independent.
PARADIGM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPARADIGM Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PARADIGM Trial Design
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- My liver tests are normal and I haven't had a rejection episode in the last 6 months.My kidney function is low and I've had a rejection episode before a transplant.I haven't had serious fungal infections like aspergillus, histoplasmosis, or coccidioidomycosis in the last year.I am 18 years old or older.My cholesterol and triglycerides levels are high and untreated.My body does not produce c-peptide when stimulated.I have not treated or unstable eye damage due to diabetes.I have severe heart problems, including a recent heart attack, poor heart function, or need for a valve replacement.I have developed proteinuria after my kidney transplant.You currently have problems with drinking alcohol or using drugs.I had a kidney or liver transplant over 6 months ago and am on specific immune-suppressing drugs.I have not received any live vaccines in the last 2 months.My liver tests are high and I've had a rejection episode before a transplant.I am not pregnant, breastfeeding, and willing to use effective birth control during and 4 months after the study.I was diagnosed with Type 1 diabetes before 40 and have been on insulin for over 5 years.I do not have active infections like hepatitis B, C, HIV, or TB.I need more than 1.0 IU/kg/day of insulin.I have had cancer after a kidney or liver transplant, but skin cancer was fully removed.I have been diagnosed with a type of hyperparathyroidism.I do not have any serious infections.I weigh over 100 kg or my BMI is over 30.My body has specific antibodies against a donor organ, detected by a special test.My kidney function is stable and I haven't had a rejection episode in the last 6 months.I have an active stomach ulcer, symptomatic gallstones, or high blood pressure in the liver.My blood pressure is high even with medication.You have a positive test for BK virus in your blood at the time of screening.I am 18 years old or older.
- Group 1: PTG with adult pancreatic islet co-transplantation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What desired outcomes underpin this clinical trial?
"This clinical trial is designed to measure the incidence of adverse events over a minimum one year period, with some participants tracked for up to two years. Secondary objectives include assessing beta cell function via Mixed Meal Tolerance Test (MMTT) and Fast-stimulated Glucose Insulin Tolerance Test (FSIGT), gauging glycemic lability through Mean Amplitude of Glycemic Excursions (MAGE) testing, and measuring hypoglycemia frequency/severity using a HYPO score."
How many individuals have volunteered to participate in this medical investigation?
"Affirmative. Clinicaltrials.gov supplies details indicating that the trial, which was first made available on July 1st 2019, is presently accepting participants. Specifically, 8 patients must be recruited across a solitary medical facility."
Is there still capacity for individuals to join this experiment?
"Affirmative. The study, initially published on July 1st 2019 and recently revised on July 7th 2022, is still actively recruiting 8 people across one location according to information hosted by clinicaltrials.gov."
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