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Intensive Dietary and Activity Counselling (IDAC)

RecruitingNAAges 3 Months - 4 MonthsAllLund University
NCT06670625 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The aim of this intervention study is to investigate if a intensive dietary and physical activity counselling during the first two years of life in children with increased (genetically) risk for Type 1 Diabetes (T1D) can promote a healthy beta-cell environment, in order to reduce increased weight gain and development of islet autoimmunity (beta-cell autoantibodies). The main hypotheses are: * Early lifestyle influences the susceptibility to islet autoimmunity (IA) by increasing beta-cell vulnerability. Introducing a "healthy beta-cell lifestyle" from infancy will reduce beta-cell vulnerability and the likelihood of IA. * Will promotion of a healthy beta-cell environment during early childhood in children with increased genetic risk of T1D reduce beta-cell stress, increased weight gain and development of islet autoantibodies? The primary objective is to determine whether an Intensive D

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📋 Eligibility rules (as published)
Inclusion Criteria: * The age of the infant at time of enrolment should be 3.0 months (13 - 17 weeks). * An increased genetic risk (7-10%) to develop beta-cell autoantibodies by the age of 6 years. Genetic inclusion criteria: Children without a T1D-FDR having HLA DR3/DR4-DQ8, DR4-DQ8/DR4-DQ8 or DR4-DQ8/DR4-DQ7 rs6901541 C/T genotype and: * for males having a genetic risk score greater than or equal to 18.2 but excluding those who are eligible for AVANT1A. * for females having a genetic risk score greater than or equal to 14.5 but excluding those who are eligible for AVANT1A. Children with a T1D-FDR, all DR3/3, DR4-DQ8/DR4-DQ7 and DR4-DQ8/x where x is none of the following protective alleles: DRB1\*1501, DQB1\*0503, DRB1\*1303 will be included regardless of genetic risk score. \- Written informed consent signed by the custodial parent(s). Exclusion Criteria: * Any medical condition, concomitant disease or treatment that may interfere with the assessments or may jeopardize the participant's safe participation in the study, as judged by the investigators. * Preterm delivery \< 36 weeks of gestation. * Any condition that could be associated with poor compliance. * Diagnosis of diabetes prior to recruitment or randomization. * Current use of any investigational drug.
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What it tests

  • IDAC+
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Where

1 site
Clinical Research Center (CRC), Bldng 60:11
Malmö, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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