Saturday, April 23, 2016

Gluten Free Diets To Prevent or Cure Type-1 Diabetes

One of my policies in blogging has been that I don't "play favorites".  I don't blog on something because I think it is a good idea, nor do I refuse to blog on something because I think it is a bad idea. I try to blog on all clinical trials which are aimed at curing type-1 diabetes no matter if I personally think they will be successful or not.  That is why I'm writing this blog on various researchers trying to cure type-1 diabetes with a gluten free diet.


There is general consensus that celiac disease and type-1 diabetes are related conditions, in that people having one are noticeably more likely to get the other.  Many researchers think that both are autoimmune diseases and that they share some genetic susceptibility, so that that someone genetically more likely to get one is also more likely to get the other.

The standard treatment for celiac disease is a gluten free diet.  Since many of the bad effects of celiac disease are triggered by gluten in the diet, reducing or eliminating gluten can dramatically reduce symptoms.

Therefore, some researchers have looked at the possibility that a gluten free diet might help type-1 diabetics as well.  The rest of this blog discusses this research, divided into two sections: Completed Studies (everything until about 2012) and Underway Studies (basically 2013 - on).

My discussion is at the end.

Completed Studies

From 1999: Gluten-free diet prevents diabetes in NOD mice.

NOD mice (the standard animal model of type-1 diabetes) were given either gluten-free or normal diets.  The diabetes rate in the normal diet was about four times higher than in the gluten-free mice, and the if they did get diabetes, the gluten-free mice got it later in life.  Both effects were statistically significant.


From 2011: Gluten Free First Year Does Not Prevent Type-1 Diabetes

This study involved 150 babies.  Half started eating gluten normally (at 6 months).  The other half delayed gluten until 12 months.  All of the babies had a family history of type-1 diabetes and a genotype (called HLA) which raised their chances of getting type-1 diabetes.

These children had their autoantibodies measured at 3 years and their type-1 diabetes status measured at 10 years.  The results were the same in both groups, so a gluten free first year did not prevent or delay either autoantibodies or actual onset of type-1.

Clinical Trial Record:

From 2012: Remission without insulin therapy on gluten-free diet in a 6-year old boy with type 1 diabetes mellitus.

This is a single case study (not a clinical trial), but it generated the interest in gluten free diets reflected in the clinical trials currently underway.  These doctors reported on the case of one newly diagnosed type-1 diabetic who immediately went on a gluten free diet, and did not need to inject insulin after that.  This patient was followed for 20 months, and did not need to use insulin during that time.  The doctors in this case were of the opinion that the gluten free diet had extended the length and strength of his honeymoon remission.  The patient was a 5 year old boy, and tested positive for the GAD autoantibody.


Underway Studies

Gluten Free Diet Starts a Phase-I Honeymoon Trial

This trial will enroll 20 people between 2 and 18 years old within 3 months of diagnosis.  All will eat a gluten free diet; there is no control group. C-peptides and insulin usage will be measured after 1 year to see if a gluten free diet results in slower or less loss of beta cells or less need for injected insulin.

This study is being run by Jannet Svensson, PhD at the Copenhagen University Hospital in Herlev, but is already fully enrolled.  She was one of the authors of the case study listed above.  This study started in March 2012 and has already finished.  It has been submitted for publication, but I have no news yet on when it will be published.

Clinical Trial Record:

Gluten Free Diet Starts a Phase-II Prevention Trial

This trial will enroll 60 people between 2 and 50 years old who have one or more autoantibodies, but are not showing other symptoms of type-1 diabetes.  Half will eat a gluten free diet and half will eat a normal diet, while both groups will get Vitamin D, Omega 3 fatty acids, and probiotics. C-peptides will be measured throughout the trial to see if a gluten free diet results in slower or less loss of beta cells.

If you are interested in enrolling, you can contact  Dr. Helena Elding Larsson at Lund University, Department of Clinical Sciences Malmö, Sweden, 20502

Clinical Trial Record:

Gluten Free Diet Starts a Phase-II Honeymoon Trial

This trial will enroll 60 people between 1 and 17 years old within 4 months of diagnosis.  Half will eat a gluten free diet and half will eat a normal diet. C-peptides will be measured after 1 year to see if a gluten free diet results in slower or less loss of beta cells.

The trial started in March 2015 and should end in March 2017 (meaning they should be finished with enrollment right about now: March 2016).  If you are interested in this study you can contact  Dr. Eba Hathout at Loma Linda University, California.

Clinical Trial Record:


Somehow I think that if gluten free diets could prevent or cure type-1 diabetes, someone would have noticed before now.  There are human populations, such as Inuit (Eskimos) and Masai, who have naturally gluten free diets.  If this theory were correct, these populations would have low or nonexistent rates of type-1 diabetes, and that would have been noticed by now.  Also, in the early 1900s (prior to the discovery of insulin) one of the common type-1 life prolonging diets was essentially gluten free, but it did not cure type-1 diabetes, either.

My basic summary is that right now, if you look at clinical trials (and ignore case studies and animal research), there is one published study, and it was unsuccessful.  In the next few months we will get one more, and two additional results in the next two years or so.  That will be a total of four studies, and should be enough to answer the question (or at least show a strong trend).

Obviously, the optimism about gluten free diets is generated from the case study.  It does appear that the child had type-1 diabetes (and was not a misdiagnosis).  I say that because they detected GAD antibodies, a marker for type-1 diabetes, and also because the researchers involved were (and are) heavily involved in type-1 research.  I just don't see them making a misdiagnosis error.  Going insulin free for 20 months after diagnosis is certainly very unusual.  Going insulin free for a short period of time after diagnosis does happen.  And we do not know how long the longest honeymoon period is. However, even taken together, 20 months insulin free is highly unusual.  Of course, the gluten free diet could just be random chance.  (That is, not causation, not correlation, but just lucky chance.)  But it is exactly the kind of coincidence that should be followed up on, and these four studies are a strong follow up.

One final point I want to make: often times I hear proponents of alternate medicine complain that their theories are ignored by mainstream medicine. Specifically they say that drug based treatments are pushed in preference to diet based treatments, so that drug companies profit.  The research described here is a strong counter example.  Given a single case study showing a diet based therapy might work, mainstream researchers have launched three clinical trials in an attempt reproduce the result.  The results will speak for themselves.

Joshua Levy 
publicjoshualevy at gmail dot com
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.