Phase-I Study of Of Gluten Free Diet In Honeymoon Type 1 Diabetes (Diabglut)
This trial will recruit 160 children, aged 3 to 18. It started in December 2015, and is expected to end in December 2020. Half of the people will be put on a gluten free diet within one month of diagnosis, and the other half will not (and will be the control group).
This study is being done in Skanes University Hospital, Lund, Region Skane, Sweden, 22185
Contact: Annelie Carlsson, MD PhD +46768267170 firstname.lastname@example.org
Contact: Iren Tiberg, PhD, nurse email@example.com
Clinical trial registry: https://clinicaltrials.gov/ct2/show/NCT03037190
My first thoughts when I saw this study were: "Why do a study like this? Does anyone really believe that a gluten free diet will cure/improve type-1 diabetes?"
The researchers included four previous studies as references for this work, but I think the one that mattered was this one:
This is the case study of a single patient (a five year old boy). He was was put on a gluten free diet a few weeks after diagnosis, and remained off insulin for 20+ months. That's an unusually strong honeymoon, and I think it is reasonable to say that the researchers are hoping that they can create that kind of honeymoon in other newly diagnosed people.
For me, case studies (like this one) represent a middle ground between anecdotes and scientific studies. I don't think they are very strong by themselves, but I do think that following them up with a research study is a good way to proceed.
The other three studies cited by the researchers as background for this research were much less dramatic. One study tried delaying introduction of gluten in the diet of babies: no effect. Another tried putting people with two antibodies on a gluten free diet before diagnosis: no effect on eventual diagnosis, but might have a small effect on beta cell survival after diagnosis. The third study was population based, and suggested that introducing gluten earlier (at 4 months, rather than later) might lower the rate of celiac diagnosed at 12 years. As a population study, I don't put a lot of weight on it, and the impact was to celiac and not type-1, in any case.
Minimal Islet Transplant at Diabetes Onset (MITO)
This is mostly a transplant trial, so I don't expect to follow it moving forward, but it is a different type of transplant, so I'm describing it here.
Most transplants are done on the most seriously impacted people with type-1 diabetes. These people often have a lot of trouble controlling their type-1, they are often already having serious complications, and are generally on the worst side of the type-1 spectrum. These are the people who often volunteer for transplantation.
This study is targeting the opposite: people who within 6 months of type-1 diagnoses, and are still generating some residual insulin. The idea is to transplant some islet cells in combination with ATG, G-CSF, and Rapamycin treatments. It's a "kitchen sink" approach. All of those treatments are in active clinical trials right now, but none of them has been shown effective so far.
I do think that it will be valuable to get data from people who are not so extremely sick when they get their transplant, although I doubt this will lead to a cure in the short term.
They are recruiting 6 people in Italy:
IRCCS San Raffaele Scientific Institute Milan, Italy, 20132
Contact: Lorenzo Piemonti, MD 0226432706 ext 39 firstname.lastname@example.org
Contact: Paola Maffi, MD email@example.com
Contact: Emauele Bosi, MD 0226432818 ext 39 firstname.lastname@example.org
T-Rex Now Can Enroll People 8 Years Old, and Older
Previously, they could enroll people as young as 12, but they have enough safe results with those kids, so that the FDA will now allow kids as young as 8 to enroll. You can read all about the technique they are using and who is eligible in my previous blogging:http://cureresearch4type1diabetes.blogspot.com/search?q=T-Rex
Also, the last time I blogged, this study was only recruiting in two locations, but now they are recruiting all over the US, from Oregon to Connecticut to Florida to UCSF, not to mention Tennessee, Missouri, Massachusetts, Indiana, and that is not a complete list. (See the Clinical Trial Record, link below, to get a complete list.)
This is a phase-II trial which is a follow on to the previous "Polyclonal T-Reg" study, which I also blogged about here:
(Look at all the postings in this link, except the first one, in order to see the history of this treatment.)
Clinical Trial Record: https://clinicaltrials.gov/ct2/show/NCT02691247
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All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.