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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Institut fur Diabetesforschung, Munich, Germany
ClinicalTrials.gov Identifier:
NCT01115621
First received: April 7, 2010
Last updated: April 30, 2010
Last verified: April 2010
History of Changes
  Purpose

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.


Condition Intervention
Type 1 Diabetes
 Other: Glutenfree diet during the first year of life

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: BABYDIET-Study - Primary Prevention of Type 1 Diabetes in Relatives at Increased Genetic Risk

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut fur Diabetesforschung, Munich, Germany:

Primary Outcome Measures:
  • Effect of dietary intervention on the development of islet autoantibodies [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Primary outcome is to compare the prevalence of iselt autoantibodies between children participating in the dietary intervention and the control group.


Secondary Outcome Measures:
  • Effect of dietary intervention on the development of Type 1 diabetes. [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Secondary outcome is to compare the prevalence of type 1 diabetes between children participating in the dietary intervention and the control group


Enrollment: 150
Study Start Date: February 2001
Estimated Study Completion Date: December 2016
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01115621

Locations
Germany
Institut für Diabetesforschung
München, Germany, 80804
Sponsors and Collaborators
Institut fur Diabetesforschung, Munich, Germany
Investigators
Principal Investigator: Anette G Ziegler, MD Institut für Diabetesforschung, München, Germany
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Dr. Anette-G. Ziegler, Institut fuer Diabetesforschung, Ingolstädter Landstr. 1, Neuherberg
ClinicalTrials.gov Identifier: NCT01115621     History of Changes
Other Study ID Numbers: ZI310/14-1
Study First Received: April 7, 2010
Last Updated: April 30, 2010
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on June 18, 2013