Intensive dietary and activity counseling for children at risk of Type 1 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This intervention focuses on providing intensive dietary and physical activity counseling to infants at increased genetic risk for Type 1 Diabetes during their first two years of life. The study aims to promote a healthy beta-cell environment to reduce weight gain and the development of islet autoimmunity. By investigating the relationship between early lifestyle choices and the susceptibility to islet autoimmunity, the study seeks to determine if a 'healthy beta-cell lifestyle' can mitigate the risk of developing diabetes-related autoantibodies. Primary outcomes will be measured through the development of autoantibodies and metabolic health indicators.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clinical Research Center (CRC), Bldng 60:11
  Malmö, Sweden Recruiting

Study contacts

• Principal investigator: Helena Elding Larsson, PhD — Lund University
• Study coordinator: Carin Andrén Aronsson, PhD
• Email: carin.andren_aronsson@med.lu.se
• Phone: +464039113

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.