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Type 1 diabetes is an autoimmune disease that occurs when the immune system attacks and destroys the insulin-producing cells in the pancreas. The Diabetes Research Institute at the University of Miami is currently offering a research protocol for patients with type 1 diabetes within 10 years of diagnosis, and between the ages of 6 – 65 years.
The purpose of this research study is to compare the safety and effectiveness of two oral medications (vitamin D and omega-3) that may slow-down or stop the progression of the autoimmune process and preserve your insulin-producing cells.
If you are interested in participating in this clinical trial, please download the application form, complete it, and email it to firstname.lastname@example.org, or fax it to 305-243-1058 or 305-243-2665. For additional information, please contact the DRI Clinical Program at 305-243-5321.
Frequently Asked Questions (FAQ)
1. How will I know if I am eligible to participate in this study?
You will need to be between the ages of 6 and 65 years and have been diagnosed with type 1 diabetes within the last 10 years.
You will also need to have evidence of some insulin production by your insulin producing cells. We can check for this by testing your levels of C-peptide in your blood. This will be done during a mixed meal tolerance test where you will drink a liquid meal containing a specific amount of protein, fat and carbohydrates and blood samples will be obtained through an IV placed in an arm vein. Your C-peptide during this test will need to be ≥0.2 ng/mL in order to be eligible.
You may find the full list of inclusion/exclusion criteria on the ClinicalTrials.gov website. You can also contact the Diabetes Research Institute at: 305-243-5321 or 305-243-6070.
2. How many patients will participate in this research study?
A total of 56 patients will participate, 28 adults and 28 children.
3. If I participate in this study, what will I have to do?
If you are eligible to participate in this research study, you will be assigned to either take a combination of omega-3 and vitamin D or vitamin D alone. Treatment assignment will be randomized, meaning that you will be assigned to a treatment group by chance, and you will have a 50% chance of being in either group, like flipping a coin.
You will have to travel to the Diabetes Research Institute in Miami every 4 months for study visits.
4. How much omega-3 and vitamin D do I have to take in this study?
The dose of omega-3 and vitamin D will depend on laboratory results obtained during the study and will be adjusted as needed.
5. Will I need to purchase omega-3 and vitamin D during my study participation?
No, omega-3 and vitamin D will be provided at no cost.
6. Will I be compensated for my participation or reimbursed for travel expenses if I get involved in this study?
No monetary compensation or reimbursement will be provided for study participation.
7. What is the duration of the study?
The study will last 2 years.
8. Can I end my participation in the study if I change my mind?
Your participation is voluntary; you may choose to leave the study at any time.