Tauroursodeoxycholic Acid (TUDCA) in New-Onset Type 1 Diabetes (NCT02218619) | Clinical Trial Compass
CompletedPhase 2
Tauroursodeoxycholic Acid (TUDCA) in New-Onset Type 1 Diabetes
United States20 participantsStarted 2015-08
Plain-language summary
Clinically, the ability to slow or prevent beta cell demise can prevent or improve the course of type 1 diabetes. The immune-mediated destruction of beta cells that is an apparent major pathological basis for the disease, has led to efforts to prevent or suppress this immune assault. Here the investigators propose to buttress the beta cell's capacity to withstand this assault by improving the function of the endoplasmic reticulum stress resolving mechanisms within these cells. The ability to do so could have a major impact on preventive and therapeutic strategies for type 1 diabetes (and possibly other types of diabetes). The type of endoplasmic reticulum stress relieving agent (TUDCA) proposed here could ultimately be applied on an anticipatory basis to individuals at high risk for type 1 diabetes.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Type 1 diabetes according to American Diabetes Association criteria
* Diagnosis of type 1 diabetes within 100 days of randomization
* One positive diabetes-related autoantibody
* Ages 18-45 years
Exclusion Criteria:
* Drugs known to affect glucose other than insulin
* Stimulated C-peptide levels \< 0.2 pmol/ml measured during a mixed meal tolerance test conducted at least 21 days from diagnosis of diabetes and within one month (37 days) of randomization to either TUDCA or placebo.
* Women during pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a drug called TUDCA in people with new-onset Type 1 diabetes — since it's now completed, has the data been published, and what did it actually show about whether TUDCA helped preserve the body's own insulin production (measured by C-peptide levels)?
2The trial tracked C-peptide over 6, 12, and 18 months as a sign of remaining beta cell function — given where my C-peptide levels are right now, is that kind of preservation still a realistic goal for me, and would it make a meaningful difference in how I manage my diabetes day to day?
3Since this is a Phase 2 trial, what does that mean for how much we know about TUDCA's safety and effectiveness — and are there any side effects or risks that came up in this study that I should be aware of?
4TUDCA is a bile acid derivative that's sometimes available as a supplement — does the completed trial data tell us anything about whether taking it outside of a clinical trial setting would be safe or useful, or is that still too uncertain to consider?
5Now that this trial is complete, are there any follow-up studies or other trials building on these results that might be worth discussing as options for someone in my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in C-peptide Measurement as Reflection of Insulin Secretion at 6 Months
Timeframe: Baseline and 6 months
2
Change in C-peptide Measurement as Reflection of Insulin Secretion at 12 Months
Timeframe: Baseline and 12 months
3
Change in C-peptide Measurement as Reflection of Insulin Secretion at 18 Months