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

Institut fur Diabetesforschung, Munich, Germany150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

150

Conditions

Type 1 Diabetes

Interventions

Glutenfree diet during the first year of lifeOTHER

Glutenfree diet during the first year of life

Eligibility

Sex: ALLMax age: 3 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Institut für Diabetesforschung

München, Germany

Outcomes

Primary Outcomes

Effect of dietary intervention on the development of islet autoantibodies

Primary outcome is to compare the prevalence of iselt autoantibodies between children participating in the dietary intervention and the control group.

Time frame: 3 years

Secondary Outcomes

Effect of dietary intervention on the development of Type 1 diabetes.

Secondary outcome is to compare the prevalence of type 1 diabetes between children participating in the dietary intervention and the control group

Time frame: 10 years

Data from ClinicalTrials.gov

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