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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by Institut fur Diabetesforschung, Munich, Germany.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01115621
First Posted: May 4, 2010
Last Update Posted: May 4, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Institut fur Diabetesforschung, Munich, Germany
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: April 7, 2010
First Posted: May 4, 2010
Last Update Posted: May 4, 2010
Last Verified: April 2010

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