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Trial to Reduce Insulin dependent diabetes in the Genetically at Risk


Dr. Dorothy Becker hosted a special chat about the TRIGR study on Tuesday, January 20, 2004. The transcript is below.

Type 1 diabetes strikes without warning unless people are in research studies that can detect autoantibodies which reflect inflammation of the pancreas' islet cells that make insulin. Once overt, its costs are high: up to $10,000 a year to treat the disease and up to $50,000 to treat its complications. It's caused by white cells from the blood which attack the pancreas' islets. Some research studies have suggested that there may be a relationship between the timing of the beginning of feeding babies formula, while others failed to show an effect. Recent research in diabetes prone mice and in a preliminary study in babies from Finland, suggest that babies who are fed a special infant formula, if the are not 100% breastfed, are less likely to get the antibodies and therefore possibly diabetes could be delayed or even prevented. Now doctors in the U.S., Canada and in Europe are conducting the TRIGR trial to see if they can prove whether or not the special infant formula helps at-risk babies-those with a parent or sibling who has type 1 or insulin dependent diabetes.

If you are pregnant and your newborn will fit the risk criteria, he or she will be wanted for the trial. The trial does not interfere with breast feeding. Babies who can't breastfeed or need formula in addition to breast milk will get safe infant formulas to see if the test formula helps prevent type 1 diabetes. For details, call 1-888-786-7813 or visit www.trigr.org.

Dorothy Becker, Professor of Pediatrics
Chief, Division of Endocrinology and Diabetes
Childrens Hospital and University of Pittsburgh

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Moderator   (server) Tue Jan 20 08:00:00 PM GMT-05:00 2004
Our chat about the TRIGR Study starts at 9pm Eastern.

Nikita 12  (66.97.230.39) Tue Jan 20 08:26:08 PM GMT-05:00 2004
hi

Daniel/FL Pumper  (64.136.27.226) Tue Jan 20 08:43:55 PM GMT-05:00 2004
hello

Moderator   (server) Tue Jan 20 08:50:00 PM GMT-05:00 2004
Our chat about TRIGR Study starts in 10 min in the 'TRIGR' room.

Daniel/FL Pumper  (64.136.27.226) Tue Jan 20 08:50:33 PM GMT-05:00 2004
what does TRIGR stand for?

Allison Sevaun, 5 dx'd @ 3; daughter to Jean, dx'd 1949  (207.213.88.135) Tue Jan 20 08:51:01 PM GMT-05:00 2004
Trial to Reduce IDDM in the Genetically at Risk.

Heidyn   (164.106.22.69) Tue Jan 20 08:51:40 PM GMT-05:00 2004
speaker?

Daniel/FL Pumper  (64.136.27.226) Tue Jan 20 08:52:22 PM GMT-05:00 2004
thanks Allison  Smile 

Allison Sevaun, 5 dx'd @ 3; daughter to Jean, dx'd 1949  (207.213.88.135) Tue Jan 20 08:53:58 PM GMT-05:00 2004
You're welcome. My daughter is participating in the study. Smile 

Daniel/FL Pumper  (64.136.27.226) Tue Jan 20 08:55:05 PM GMT-05:00 2004
That's exciting I hope it is helpful.

Jeff Hitchcock Marissa, 16, dx'd at 2  (216.68.227.252) Tue Jan 20 08:55:24 PM GMT-05:00 2004
Good evening everyone. I'd like to welcome Dr. Dorothy Becker, Professor of Pediatrics and Chief, Division of Endocrinology and Diabetes, at Childrens Hospital and University of Pittsburgh. Dr. Becker is hosting tonight's chat about the TRIGR study.

Allison Sevaun, 5 dx'd @ 3; daughter to Jean, dx'd 1949  (207.213.88.135) Tue Jan 20 08:56:21 PM GMT-05:00 2004
Good evening. Welcome, Dr. Becker.

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 08:56:46 PM GMT-05:00 2004
Thanks for inviting me.

Brenda H. mom of Marissa, 16, dx'd 9/89  (216.68.227.252) Tue Jan 20 08:57:29 PM GMT-05:00 2004
How do you know if your child is "genetically at risk?"

Allison Sevaun, 5 dx'd @ 3; daughter to Jean, dx'd 1949  (207.213.88.135) Tue Jan 20 08:58:22 PM GMT-05:00 2004
I am particularly interested in this chat this evening as my daughter is participating in the TRIGR study at UCLA under Dr. Lisa Rogers.

Brenda H. mom of Marissa, 16, dx'd 9/89  (216.68.227.252) Tue Jan 20 08:59:07 PM GMT-05:00 2004
We previously had our kids in the DAISY program. They have had blood drawn and did not have the identifying markers (genes???). It was about 7 yrs. ago so I'm not sure about the facts.

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 08:59:21 PM GMT-05:00 2004
Cord blood is taken from the participating babies at birth and sent to a special lab that looks for genes known t be associated with type 1 diabetes. These genes can actually be measured at any time. They give risk compared to the general population but don't say a person will or will not get diabetes.

Brenda H. mom of Marissa, 16, dx'd 9/89  (216.68.227.252) Tue Jan 20 09:01:46 PM GMT-05:00 2004
Well, I suppose our kids cannot participate at this point anyway since they are 13 and 10--no cord blood available. But, this sounds like a great idea for expectant parents. Is this for all expectant parents or just those who have someone with Type 1 in their family?

Allison Sevaun, 5 dx'd @ 3; daughter to Jean, dx'd 1949  (207.213.88.135) Tue Jan 20 09:02:01 PM GMT-05:00 2004
Is it true, Dr. Becker, that a much larger percentage of the population tests positive with the HLA testing that is done on the cord blood than actually become diabetic?

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 09:03:46 PM GMT-05:00 2004
TRIGR is recruiting newborn infants of mothers or fathers who themselves have diabetes or another child with diabetes. Babies are recruited before they are born.

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 09:04:53 PM GMT-05:00 2004
Allison, yes. 40% of the general population has the diabetes susceptibility genes and only 6% of those will get diabetes. The risk for getting diabetes is higher if there is a family member with it.

Brenda H. mom of Marissa, 16, dx'd 9/89  (216.68.227.252) Tue Jan 20 09:05:57 PM GMT-05:00 2004
Am I correct in assuming that funding is the issue? And/or it'd be difficult to obtain and test the cord blood from EVERY infant in the U.S.

Allison Sevaun, 5 dx'd @ 3; daughter to Jean, dx'd 1949  (207.213.88.135) Tue Jan 20 09:07:54 PM GMT-05:00 2004
Both my mother and my son are type 1, so after my daughter's test, they gave her a 10-12% chance of becoming diabetic.

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 09:08:32 PM GMT-05:00 2004
Yes funding is always a problem. This study is funded by NIH, JDRF, the Canadian Institute of Health and the European Union amongst others. There are other studies without an intervention to follow babies with higher risk genes in the general population to see what might precipitate diabetes.

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 09:09:06 PM GMT-05:00 2004
Allison, was that based on genes?

Allison Sevaun, 5 dx'd @ 3; daughter to Jean, dx'd 1949  (207.213.88.135) Tue Jan 20 09:09:23 PM GMT-05:00 2004
HLA testing of her cord blood.

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 09:10:24 PM GMT-05:00 2004
Allison, That sounds about right depending on which genes she had.

Brenda H. mom of Marissa, 16, dx'd 9/89  (216.68.227.252) Tue Jan 20 09:11:20 PM GMT-05:00 2004
So, if an infant is deemed "at risk," what is the next step? Is it like the DPT-1 where some were given insulin, some placebos, etc.? Showing I haven't researched this!

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 09:13:30 PM GMT-05:00 2004
Brenda, The question is whether the type of infant formula fed to the baby in the first six months affects the risk of developing antibodies against the insulin-making cells and future diabetes. Therefore, babies receive either regular formula or a formula with protein broken down if and when mother decides not to exclusively breast feed.

Brenda H. mom of Marissa, 16, dx'd 9/89  (216.68.227.252) Tue Jan 20 09:17:45 PM GMT-05:00 2004
Allison, how are you feeding your daughter?

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 09:19:10 PM GMT-05:00 2004
By doing this TRIGR study, we hope to find a way to decrease diabetes in the future. It is a big deal because if the study works, it will change feeding practices around the world. On the other hand, we should not interfere with established feeding practice if it turns out that our test formula has no effect. difference, then it would be a

Brenda H. mom of Marissa, 16, dx'd 9/89  (216.68.227.252) Tue Jan 20 09:19:26 PM GMT-05:00 2004
And, Dr. Becker, does this have any relation to the cow's milk theory? I think I'm confused. Of course, I seem to recall conflicting studies about breast feeding and Type 1 and know of at least one mom who was still breast feeding when her son was dx'd 15 or so yrs. ago.

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 09:21:29 PM GMT-05:00 2004
Brenda, yes it is related to what was known previously as the "Cow Milk Theory." There are studies suggesting that cow milk is related to diabetes and others showing no relationship. Animal studies (rats and mice) suggest that formulas with broken down protein (both cow milk and soy) prevent diabetes.

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 09:23:20 PM GMT-05:00 2004
Just to add to my previous comment, we have to do the TRIGR study as it is the only way to resolve the conflicting results from what is known as natural history studies.

Brenda H. mom of Marissa, 16, dx'd 9/89  (216.68.227.252) Tue Jan 20 09:25:54 PM GMT-05:00 2004
So, Dr. Becker, do you think that cows' milk alone might be a trigger or are there probably multiple triggers?

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 09:26:46 PM GMT-05:00 2004
If any of you know someone who is pregnant and has a family history of diabetes, the TRIGR trial really needs their help for this study which is known as an intervention study.

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 09:27:59 PM GMT-05:00 2004
Brenda, my personal opinion is that there are multiple environmental triggers. But milk is important as it is usually the first environmental exposure experienced by a newborn.

Brenda H. mom of Marissa, 16, dx'd 9/89  (216.68.227.252) Tue Jan 20 09:28:52 PM GMT-05:00 2004
There are several moms on our parents' mailing list who are pregnant; perhaps we should send out a msg to the list about the study. Who should they contact if they want to participate?

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 09:32:43 PM GMT-05:00 2004
There are six major centers in the U.S. These are: Pittsburgh, Seattle, St. Louis, New York, Los Angeles and Puerto Rico. We are also able to recruit babies almost anywhere, including Canada, where there is a big network. You do not have to live in one of the listed cities to participate in the study. The contacts are the U.S. coordinator, Peggy Franciscus at 412/692-5250 or you can call 1-888-STOPTID.

Allison Sevaun, 5 dx'd @ 3; daughter to Jean, dx'd 1949  (207.213.88.135) Tue Jan 20 09:33:11 PM GMT-05:00 2004
It's a pretty cool deal to participate. I was supplied "study formula" for the first six months of my daughter's life, and I had to keep her on a cow-protein free diet, which is very easy to do.

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 09:34:06 PM GMT-05:00 2004
Allison, thanks for your participation in the study. It's people like you that will give us the answer.

Brenda H. mom of Marissa, 16, dx'd 9/89  (216.68.227.252) Tue Jan 20 09:35:15 PM GMT-05:00 2004
On a somewhat related topic, do you recommend that expectant parents bank cord blood for future use/study?

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 09:35:47 PM GMT-05:00 2004
Brenda, regarding your mailing list - there are a lot of advantages in being part of this study including the availability of dietary advice by a qualified nutritionist for six months. We work together with the baby's doctor.

Allison Sevaun, 5 dx'd @ 3; daughter to Jean, dx'd 1949  (207.213.88.135) Tue Jan 20 09:36:31 PM GMT-05:00 2004
God willing, type 1 will skip my daughter, but if it helps at all to figure this thing out, it's definitely worth participating. My daughter has also had to have blood draws every 3 months, but we're compensated for them, and I take that money and put it towards her future by buying savings bonds with it.

Brenda H. mom of Marissa, 16, dx'd 9/89  (216.68.227.252) Tue Jan 20 09:36:43 PM GMT-05:00 2004
We will send out something this week and try to get you more participants. Smile 

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 09:37:57 PM GMT-05:00 2004
Brenda, I think every drop of blood is precious and if the opportunity arises to bank it, the opportunity should not be missed.

Brenda H. mom of Marissa, 16, dx'd 9/89  (216.68.227.252) Tue Jan 20 09:39:27 PM GMT-05:00 2004
Do you know of any places to store the cord blood?

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 09:39:39 PM GMT-05:00 2004
Brenda, thank you very much. That would be great. Smile 

Allison Sevaun, 5 dx'd @ 3; daughter to Jean, dx'd 1949  (207.213.88.135) Tue Jan 20 09:40:07 PM GMT-05:00 2004
My daughter's blood went to StemCyte.

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 09:40:42 PM GMT-05:00 2004
Brenda, at the moment there is a lot of discussion regarding storage of cord blood for research studies but nothing is funded or finalized yet.

Allison Sevaun, 5 dx'd @ 3; daughter to Jean, dx'd 1949  (207.213.88.135) Tue Jan 20 09:40:49 PM GMT-05:00 2004
There was plenty of cord blood to do the TRIGR testing, the hospital testing and bank the rest.

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 09:42:05 PM GMT-05:00 2004
Allison, that is correct. Quite a few TRIGR participants have chosen to bank the rest of the cord blood.

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 09:46:35 PM GMT-05:00 2004
For interest: TRIGR is the very first nutritional intervention study in type 1 diabetes. It is also the very first trial to attempt to prevent the inflammation of islet cells rather than wait till that has already happened, like DPT-1. It's also the very first international study so that people of all nations can be included. This is important as there may be differences around the world.

Brenda H. mom of Marissa, 16, dx'd 9/89  (216.68.227.252) Tue Jan 20 09:47:50 PM GMT-05:00 2004
Dr. Becker, what happens with children who are "at risk" but are breast fed at least 9 months?

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 09:50:03 PM GMT-05:00 2004
Brenda, breast fed babies are included in the study as we never know when a baby may need a bottle even if this is not the intention at birth.

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 09:52:51 PM GMT-05:00 2004
Brenda, it is possible that your question relates to protection from diabetes by breast feeding. Some studies suggest that early formula feeding increases the risk of diabetes. It is not clear from these studies whether it is the breast feeding that protects or whether there is a diabetes-promoting factor in the formula. As was mentioned earlier, breast feeding does not totally protect from diabetes.

Brenda H. mom of Marissa, 16, dx'd 9/89  (216.68.227.252) Tue Jan 20 09:54:24 PM GMT-05:00 2004
I agree that exclusive breast fedding is NOT a protection against diabetes; just not sure how breast fed children are studied. I will look up more info on TRIGR tomorrow so I understand it better.

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 09:56:16 PM GMT-05:00 2004
For everybody's interest, we need about 2000 eligible babies in this study. As of today, we have 617 enrolled around the world. Our goal is to finish enrollment of all babies by the end of next year. This is why we would like to spread the word.

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 09:57:55 PM GMT-05:00 2004
Brenda, you can go to www.TRIGR.org. Also, if you search for TRIGR, you will find web sites around the world. Any other specific questions?

Brenda H. mom of Marissa, 16, dx'd 9/89  (216.68.227.252) Tue Jan 20 09:58:02 PM GMT-05:00 2004
Once the child's cord blood is taken, how many more times does the child need to give blood? Years?

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 10:00:03 PM GMT-05:00 2004
Blood is drawn for measurement of cow milk antibodies and islet cell antibodies at 3, 6 and 12 months and then annually until age 10. Blood sugars are measured and a glucose tolerance test is done at age 6 and 10 years.

Jeff Hitchcock Marissa, 16, dx'd at 2  (216.68.227.252) Tue Jan 20 10:00:22 PM GMT-05:00 2004
Dr. Becker, I'd like to thank you for taking the time to chat with us this evening about the TRIGR study. I'll have a transcript online tomorrow for everyone to review, as well as links to the TRIGR web site.

This room will remain open until 11:30 pm Eastern.

Brenda H. mom of Marissa, 16, dx'd 9/89  (216.68.227.252) Tue Jan 20 10:00:30 PM GMT-05:00 2004
Great, thanks for all the information.

Allison Sevaun, 5 dx'd @ 3; daughter to Jean, dx'd 1949  (207.213.88.135) Tue Jan 20 10:00:31 PM GMT-05:00 2004
My daughter has had blood drawn every 3 months until one year and then will do it once more at 18 months, Brenda.

Allison Sevaun, 5 dx'd @ 3; daughter to Jean, dx'd 1949  (207.213.88.135) Tue Jan 20 10:00:57 PM GMT-05:00 2004
And once a year after that. They follow for 10 years.

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 10:01:40 PM GMT-05:00 2004
Sorry, in the rapidity of typing, I forgot the 18 months.

Allison Sevaun, 5 dx'd @ 3; daughter to Jean, dx'd 1949  (207.213.88.135) Tue Jan 20 10:03:45 PM GMT-05:00 2004
Nice to "meet" you, Dr. Becker. Thanks for the chat.

Allison Sevaun, 5 dx'd @ 3; daughter to Jean, dx'd 1949  (207.213.88.135) Tue Jan 20 10:05:10 PM GMT-05:00 2004
Brenda, if anyone from CWD interested in participating in the study would like to ask me any questions about my experience with participating so far, I'd be happy to help.

Dr. Dorothy Becker Guest Speaker  (151.195.177.113) Tue Jan 20 10:05:57 PM GMT-05:00 2004
I hope this was helpful and i didnt use too much medical jargon

Brenda H. mom of Marissa, 16, dx'd 9/89  (216.68.227.252) Tue Jan 20 10:08:47 PM GMT-05:00 2004
Thanks again Dr. Becker.
Allison, I will track you down as our resident expert. LOL 

Allison Sevaun, 5 dx'd @ 3; daughter to Jean, dx'd 1949  (207.213.88.135) Tue Jan 20 10:09:37 PM GMT-05:00 2004
Hey, Brenda, off the subject, may I have an email addy for Laura B. I've got some questions about the July conference and would like to offer my volunteer services again.

Sweet Survivor   (67.24.82.123) Tue Jan 20 11:00:58 PM GMT-05:00 2004
looks like I missed this session. Sweet Survivor Razz 

Moderator   (server) Tue Jan 20 11:25:00 PM GMT-05:00 2004
This room will close in five minutes. Please move to a new room.



                 
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