Nutritional Intervention to Prevent Diabetes

Completed · Not applicable · Has a placebo group

Conditions studied: Type 1 Diabetes Mellitus

In brief

Type 1 Diabetes (T1D) is an autoimmune disease. This means that the immune system (the part of the body which helps fight infections) mistakenly attacks and destroys the cells that produce insulin (islet cells found in the pancreas). As these cells are destroyed, the body's ability to produce insulin decreases. The autoimmune process is thought to be initiated by a gene-environment interaction. The genetics involved in the development of T1D are fairly well understood. There is a higher risk of developing T1D with the presence of the human leukocyte antigen (HLA) DR3 or DR4. It is also known that not everyone with these genes actually develops T1D. Therefore, one or more environmental factors are thought to contribute to the process of developing T1D. The consumption of the anti-inflammatory fatty acids, the omega-3 fatty acids, has decreased significantly in the past 100 years. At the same time a rise in the incidence of T1D, especially in young children has occurred. Because of the warnings to eliminate fish during pregnancy, pregnant women are consuming even less omega-3 fatty acids during fetal development. Observations have been made that children who have received omega-3 fatty acid supplementation have a lower risk of T1D. Omega-3 fatty acids could have a protective effect that may occur during pregnancy, infancy, or both. The mechanism of this protection may be due to the DHA mediated suppression of the inflammatory response. Patients at higher risk for T1D have an increased pro-inflammatory environment. We hypothesize that DHA supplementation during pregnancy and early childhood will block the initial pro-inflammatory events and prevent development of islet cell autoimmunity in children at higher risk for T1D. This study is a feasibility study to determine if a full-scale DHA supplementation study will be implemented. If a full study is implemented, the primary outcome will be to determine if nutritional supplementation with omega-3 fatty acids during the last trimester of a mother's pregnancy and/or the first three years of life for children who are at higher risk of T1D will prevent the development of islet autoimmunity.

Key facts

Study ID

NCT00333554

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

99

Starts

2006-06-01

Expected to finish

2013-04-01

Last updated by the study team

2020-04-29

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pregnant mothers are eligible for enrollment into this study if they:
• Have T1D or the child's father, or a full or half-sibling of the child has T1D
• Are 18 years of age or older
• Are in their third trimester of pregnancy (i.e. gestation is 24 weeks or longer)
• Have understood and signed a written informed consent and HIPAA authorization
• Are willing to undergo randomization to ensure that equal numbers receive the DHA study substance versus the control
• Infants are eligible for enrollment into this study if they:
• Are less than or equal to six months of age on the date of randomization
• Are found to be at risk for type 1 diabetes because they have a mother, father or full or half-sibling with T1D AND
• have a DR3 or DR4 allele OR
• have another relative (includes both 1st and 2nd degree relatives) with T1D (multiplex family)
• Have a parent or legal guardian who has understood and signed a written informed consent and HIPAA authorization
• Have a parent(s) or legal guardian(s) who are willing for their baby to undergo randomization to ensure that equal numbers receive the DHA study substance versus the control

You may not qualify if…

• Pregnant mothers are NOT eligible for enrollment into this study if they:
• Have any condition the investigator believes will put the mother or her fetus at an unacceptable medical risk for participation in this study
• Have a known complication of pregnancy causing an increased risk for the mother or fetus prior to entry into the study
• Have previously had multiple (2 or more) pre-term births (<36 weeks)
• Are diabetic and have a known HbA1c greater than 9% at anytime during the pregnancy (however, healthy infants after birth may qualify in spite of the above restrictions during pregnancy)
• Plan to take DHA supplementation during the study
• Infants are NOT eligible for enrollment into this study if they:
• Have any condition the investigator believes will put the subject at an unacceptable medical risk for participation in this study
• Have a mother with a condition the investigator believes will put her at an unacceptable medical risk for participation in this study
• Have a nursing mother who plans to take DHA supplementation or has a parent or legal guardian who plans to provide supplementation to his/her infant independently during the study
• Have a protective allele (DQB1*0602 or DRB1*0403)
• Were born prior to 36 weeks gestation and require a pre-term infant formula

Where it is running

• Childrens Hospital of Los Angeles — Los Angeles, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Indiana University-Riley Hospital for Children — Indianapolis, Indiana, United States
• University of Iowa Health Care — Iowa City, Iowa, United States
• Joslin Diabetes Center — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• The Children's Mercy Hospital — Kansas City, Missouri, United States
• Utah Diabetes Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.