Nutritional Prevention Pilot Trial for Type 1 Diabetes (MIP)

This study has been completed.
Sponsor:
Collaborators:
Academy of Finland
European Union
Juvenile Diabetes Research Foundation
Diabetes Research Foundation, Finland
Novo Nordisk A/S
Information provided by (Responsible Party):
Mikael Knip, Helsinki University
ClinicalTrials.gov Identifier:
NCT00570102
First received: December 7, 2007
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes Mellitus
Dietary Supplement: A highly hydrolyzed formula
Dietary Supplement: A regular cow's milk based formula
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Trial to Reduce IDDM in the Genetically at Risk (TRIGR): the Pilot Study

Resource links provided by NLM:


Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • Positivity for two or more diabetes-associated autoantibodies and/or clinical type 1 diabetes [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Enrollment: 230
Study Start Date: February 1995
Study Completion Date: January 2008
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A highly hydrolyzed casein formula Dietary Supplement: A highly hydrolyzed formula
Weaning to a highly hydrolyzed formula, avoidance of all supplemental food containing cow's milk proteins and/or bovine serum albumin up to the age of 6-8 months
Placebo Comparator: A conventiona cow's milk based formula Dietary Supplement: A regular cow's milk based formula
Weaning to a regular cow's milk based formula supplemented with 20% of the highly hydrolyzed formula used in arm 1 to make the study formulas similar in smell and taste, avoidance of all supplemental food containing cow's milk proteins and/or bovine serum albumin

Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570102

Locations
Finland
Jorvi Hospital
Espoo, Finland, 02740
National Public Health Institute
Helsinki, Finland, 00300
Helsinki University Hospital, Maternity Hospital
Helsinki, Finland, 00610
University of Helsinki, Hospital for Children and Adolescents
Helsinki, Finland, FIN-00290
University of Helsinki, Department of Obstetrics and Gynecology
Helsinki, Finland, 00290
Kanta-Häme Central Hospital, Department of Pediatrics
Hämeenlinna, Finland, 13530
North Karelia Central Hospital
Joensuu, Finland, 80210
Central Finland Central Hospital
Jyväskylä, Finland, 40620
Kymenlaakso Central Hospital, Department of Pediatrics
Kotka, Finland, 48210
University of Kuopio, Department of Pediatrics
Kuopio, Finland, 70210
Päijät-Häme Central Hospital
Lahti, Finland, 15850
South Karelia Central Hospital
Lappeenranta, Finland, 53130
University of Oulu, Department of Pediatrics
Oulu, Finland, 90014
Satakunta Central Hospital
Pori, Finland, 28500
South Ostrobothnia Central Hospital
Seinäjoki, Finland, 60220
Tampere University Hospital, Department of Pediatrics
Tampere, Finland, 33520
University of Turku, Department of Virology
Turku, Finland, 20520
Vaasa Central Hospital
Vaasa, Finland, 65130
Sponsors and Collaborators
Helsinki University
Academy of Finland
European Union
Juvenile Diabetes Research Foundation
Diabetes Research Foundation, Finland
Novo Nordisk A/S
Investigators
Principal Investigator: Hans K Åkerlom, MD, PhD University of Helsinki, Helsinki, Finland
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mikael Knip, Professor of Pediatrics, Helsinki University
ClinicalTrials.gov Identifier: NCT00570102     History of Changes
Other Study ID Numbers: 195003, BHM4-CT96-0233
Study First Received: December 7, 2007
Last Updated: November 27, 2012
Health Authority: Finland: Ethics Committee

Keywords provided by Helsinki University:
dietary manipulation
infants
feasibility
Type 1 Diabetes Mellitus, Beta-cell Autoimmunity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 22, 2014