The Nutritional Intervention to Prevent Diabetes (NIP) Study

(This study is no longer recruiting patients)

New: NIP participant brochure

• Background
• Who can be in the study?
• What does participating involve?
• What are the benefits of being in the study?
• Where can I find clinical centers who are recruiting?

Background

Type 1 diabetes is an autoimmune disease which generally begins during childhood. It occurs when the immune system - there to help your body fight infection - mistakenly attacks your insulin producing cells. When these cells are destroyed your body can no longer make insulin. This is how type 1 diabetes happens.

The Nutritional Intervention to Prevent Type 1 Diabetes Pilot Study will help us learn more about a dietary substance, docosahexaenoic acid (DHA). DHA is important for brain and eye development and has also helped people with autoimmune diseases that are similar to diabetes. Everyone gets some DHA in his or her diet, but we want to see if giving more DHA will do even more good. To test this idea, we would have to start early, well before the immune system begins its attack. We want to start before 6 months of age, even before birth. DHA can be found in fish, but the DHA in this pilot is taken from plant sources, so there's no need to worry about the bad effects of mercury or other toxic materials. Remember this is a pilot study which will only tell us if a larger study can be done, it will not tell us if DHA will prevent the first step towards type 1 diabetes.

Who can be in the study?

• Pregnant women in their 3rd trimester (more than 24 weeks) may enroll in the study if the baby they are expecting has a relative (mother, father, sister, brother, half-sister, or half- brother) with type 1 diabetes. After the baby is born, a blood test is required to determine their eligibility.
• Babies up to five months old may also be enrolled in the study if they have a relative with type 1 diabetes. They will require a blood test to determine eligibility.

What does participating involve?

If pregnant, you will take four capsules a day during your third trimester. If nursing, you will also be asked to take four capsules a day.

• The capsules will contain either DHA or an ingredient that does nothing at all called a placebo.
• Neither you nor the study staff will know if you are taking the capsules with DHA or the capsules with placebo.

If your baby is on infant formula, you will be asked to use formula provided by the study. All study formula will contain some DHA.

You and your baby will need to make regular visits to the study site.

• We will collect a sample of your baby's blood.
• We will ask about your baby's diet and your diet (if you are pregnant or nursing).
• If you are nursing, you will need to bring in a sample of your breast milk.
• We will also ask other health questions.

It is anticipated that babies will participate in the study for at least 1 year.

What are the benefits of being in this pilot study?

• You might learn if your baby is at risk for developing type 1 diabetes.
• If the pilot study is successful your baby might become part of a larger study to determine if type 1 diabetes can be prevented.
• You and your baby will be contributing to diabetes research.

What clinical sites are recruiting for this pilot study?

If you wish to see if you and/or your baby might be eligible for this study and/or for more information, please contact one of the participating sites listed. Note that participants need to be within a reasonable distance of the site and the delivery hospital.

• University of California, San Francisco
  San Francisco, CA
  415-353-9084
  
• Children's Hospital Los Angeles
  Los Angeles, CA
  888-835-3761
  
• Children's Hospital of Orange County
  Orange, CA
  714-532-8613 or 714-532-8642
  
• The Children's Mercy Hospital
  Kansas City, MO
  816-983-6529
  
• Indiana University, Riley Hospital for Children
  Indianapolis, IN
  866-230-8486
  
• Joslin Diabetes Center
  Beth Israel Deaconess Medical Center
  Boston, MA
  617-732-2647
  
• University of Iowa
  Children's Hospital of Iowa
  Iowa City, IA
  866-309-0837
  
• University of Minnesota
  Minneapolis, MN
  612-625-7931
  pete5601@umn.edu
  
• University of Utah
  Utah Diabetes Center
  Salt Lake City, UT
  801-587-3972