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

Institut fur Diabetesforschung, Munich, Germany

Status: Unknown

Conditions: Type 1 Diabetes

Treatments: Other: Glutenfree diet during the first year of life

Study type: Interventional

Funder types: Other

Identifiers

NCT01115621

ZI310/14-1

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: Under 3 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Glutenfree diet

Active Comparator group

Description:

Glutenfree diet during the first year of life

Treatment:

Other: Glutenfree diet during the first year of life

Control - normal diet

No Intervention group