Nutritional Prevention Pilot Trial for Type 1 Diabetes (MIP)

November 27, 2012 updated by: Mikael Knip, University of Helsinki

Trial to Reduce IDDM in the Genetically at Risk (TRIGR): the Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Espoo, Finland, 02740
        • Jorvi Hospital
      • Helsinki, Finland, 00290
        • University of Helsinki, Department of Obstetrics and Gynecology
      • Helsinki, Finland, 00300
        • National Public Health Institute
      • Helsinki, Finland, 00610
        • Helsinki University Hospital, Maternity Hospital
      • Helsinki, Finland, FIN-00290
        • University of Helsinki, Hospital for Children and Adolescents
      • Hämeenlinna, Finland, 13530
        • Kanta-Häme Central Hospital, Department of Pediatrics
      • Joensuu, Finland, 80210
        • North Karelia Central Hospital
      • Jyväskylä, Finland, 40620
        • Central Finland Central Hospital
      • Kotka, Finland, 48210
        • Kymenlaakso Central Hospital, Department of Pediatrics
      • Kuopio, Finland, 70210
        • University of Kuopio, Department of Pediatrics
      • Lahti, Finland, 15850
        • Päijät-Häme Central Hospital
      • Lappeenranta, Finland, 53130
        • South Karelia Central Hospital
      • Oulu, Finland, 90014
        • University of Oulu, Department of Pediatrics
      • Pori, Finland, 28500
        • Satakunta Central Hospital
      • Seinäjoki, Finland, 60220
        • South Ostrobothnia Central Hospital
      • Tampere, Finland, 33520
        • Tampere University Hospital, Department of Pediatrics
      • Turku, Finland, 20520
        • University of Turku, Department of Virology
      • Vaasa, Finland, 65130
        • Vaasa Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 week (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Positivity for two or more diabetes-associated autoantibodies and/or clinical type 1 diabetes
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

Novo Nordisk A/S
Juvenile Diabetes Research Foundation
European Union
Academy of Finland
Diabetes Research Foundation, Finland

Investigators

  • Principal Investigator: Hans K Åkerlom, MD, PhD, University of Helsinki, Helsinki, Finland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1995

Primary Completion (Actual)

March 1, 2004

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

December 7, 2007

First Submitted That Met QC Criteria

December 7, 2007

First Posted (Estimate)

December 10, 2007

Study Record Updates

Last Update Posted (Estimate)

November 28, 2012

Last Update Submitted That Met QC Criteria

November 27, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 195003 (Registry Identifier: JAPIC-CTI)
  • BHM4-CT96-0233

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 1 Diabetes Mellitus

Clinical Trials on A highly hydrolyzed formula

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe