The Nutritional Intervention to Prevent Diabetes (NIP) Study

Status: No Longer Recruiting

Eligibility Criteria

To join this study, you must fulfill the conditions below:

• 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.

About this Study

The Nutritional Intervention to Prevent Type 1 Diabetes Pilot Study (NIP) will help us learn more about a dietary substance, docosahexaenoic acid (DHA). DHA is a natural ingredient found in mother's breast milk and in various foods.

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.

This research is being done as a pilot study, which is a test run - a small study of just 90 babies. The pilot study will not tell us if DHA will prevent type 1 diabetes, but it will tell us if it is possible to do a larger study.

What will I be asked to do?

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

Benefits

• 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.

Participation

To see if you might be eligible for this study and for a referral to a TrialNet site:

• Complete the online screening,
• Call toll free anytime 1 - 800 - HALT - DM1 (1-800-425-8361)
• Contact a participating center.

The blood test to determine whether or not you are at risk for Type 1 Diabetes is part of the Natural History study. Please see the list of Clinical Centers for more information.

Information will be kept confidential.