BABYDIET-Study - Primary Prevention of Type 1 Diabetes in Relatives at Increased Genetic Risk

April 30, 2010 updated by: Institut fur Diabetesforschung, Munich, Germany
The major goals of this project are to determine whether primary intervention through delayed introduction of dietary gluten is feasible and could reduce the incidence of islet autoimmunity in high-risk first degree relatives of patients with type 1 diabetes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

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

  • Germany
      • München, Germany, 80804
        • Institut für Diabetesforschung

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

No older than 3 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Newborn offspring or siblings of patients with type 1 diabetes with a HLA genotype conferring a high diabetes risk

Exclusion Criteria:

  • If infants have an illness or birth defect that precludes long-term follow-up or involves use of treatment that may alter the natural history of diabetes

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Glutenfree diet
Glutenfree diet during the first year of life
Other: Glutenfree diet during the first year of life
Glutenfree diet during the first year of life
NO_INTERVENTION: Control - normal diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of dietary intervention on the development of islet autoantibodies
Time Frame: 3 years
Primary outcome is to compare the prevalence of iselt autoantibodies between children participating in the dietary intervention and the control group.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of dietary intervention on the development of Type 1 diabetes.
Time Frame: 10 years
Secondary outcome is to compare the prevalence of type 1 diabetes between children participating in the dietary intervention and the control group
10 years

Collaborators and Investigators

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

Sponsor

Institut fur Diabetesforschung, Munich, Germany

Investigators

  • Principal Investigator: Anette G Ziegler, MD, Institut für Diabetesforschung, München, Germany

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

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, 2001

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

April 7, 2010

First Submitted That Met QC Criteria

April 30, 2010

First Posted (ESTIMATE)

May 4, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 4, 2010

Last Update Submitted That Met QC Criteria

April 30, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZI310/14-1

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.

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