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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01115621
• Date of registration: 07/04/2010
• Prospective Registration: No
• Primary sponsor: Institut fur Diabetesforschung, Munich, Germany
• Public title: BABYDIET-Study - Primary Prevention of Type 1 Diabetes in Relatives at Increased Genetic Risk
• Scientific title: BABYDIET-Study - Primary Prevention of Type 1 Diabetes in Relatives at Increased Genetic Risk
• Date of first enrolment: February 2001
• Target sample size: 150
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01115621
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Anette G Ziegler, MD
• Affiliation: Institut für Diabetesforschung, München, Germany

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: 3 Months
Gender: Both

Health Condition(s) or Problem(s) studied

Type 1 Diabetes

Intervention(s)

Other: Glutenfree diet during the first year of life

Primary Outcome(s)

Effect of dietary intervention on the development of islet autoantibodies [Time Frame: 3 years]

Secondary Outcome(s)

Effect of dietary intervention on the development of Type 1 diabetes. [Time Frame: 10 years]

Secondary ID(s)

ZI310/14-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors