Nutritional Prevention Pilot Trial for Type 1 Diabetes (MIP)

University of Helsinki

Status and phase

Completed

Phase 2

Conditions

Type 1 Diabetes Mellitus

Treatments

Dietary Supplement: A highly hydrolyzed formula

Dietary Supplement: A regular cow's milk based formula

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00570102

BHM4-CT96-0233

195003

Details and patient eligibility

About

The overall objective of the study is to assess whether complete avoidance of cow's milk (CM) proteins, for at least the first 6 months of life, prevents type 1 diabetes (insulin-dependent diabetes mellitus, IDDM) in genetically susceptible children who have a mother, biological father or sibling affected by type 1 diabetes.

Full description

Among the environmental factors leading to type 1 diabetes in childhood, the most important are certain viral infections and possibly some dietary factors. Among the latter cow's milk proteins are of special interest. They have been shown to be involved in the pancreatic beta-cell lesion in animal experiments. In humans there are some indications of a role of early exposure to cow's milk proteins as a risk factor for later type 1 diabetes. The hypothesis has not been confirmed, but a randomized, controlled double-blinded intervention trial should provide a definite answer.

This study aims at assessing whether one can decrease the future incidence of beta-cell autoimmunity and/or type 1 diabetes in children who have an increased genetic risk for the disease, by administering in infancy after breast feeding until the age of 6-8 months such a formula, in which the cow's milk proteins have been hydrolyzed to smaller peptides. The children in the control group, carrying a similar increased genetic risk, will receive a conventional cow's milk based formula .

This project is a pilot multicenter trial comprising 15 hospitals in Finland.

Enrollment

230 patients

Sex

All

Ages

1 to 7 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

the participant must have a mother, biological father or sibling with type 1 diabetes
the participant must carry a susceptible HLA genotype(HLA-DQB1*02 and/or DQB1*0302 without protective alleles (DQB1*0301, *0602 and *0603)

Exclusion criteria

no telephone
no accessibility to any of the research centers
inability of parents to understand the study and instructions
unwillingness/inability to feed the infant CM-containing food for any reason (e.g. religious, cultural reasons)
gestational age less than 36 weeks
Any severe illness such as chromosomal abnormalities, congenital malformations, respiratory failure, enzyme deficiencies of the newborn.
the newborn infant has received any cow's milk-based product prior to randomization