Intensive Dietary and Activity Counselling (IDAC)

Launched by LUND UNIVERSITY · Oct 31, 2024

Keywords

ClinConnect Summary

The Intensive Dietary and Activity Counselling (IDAC) trial is studying whether providing intensive advice on diet and physical activity in the first two years of life can help children at higher risk for Type 1 Diabetes (T1D) maintain healthier blood sugar levels and avoid weight gain. Researchers believe that teaching families a "healthy beta-cell lifestyle" early on may protect the beta cells in the pancreas, which are responsible for insulin production, and reduce the chance of developing autoimmunity, a condition where the body's immune system mistakenly attacks its own cells.

To participate in this study, children must be between 3 to 4 months old and have a higher genetic risk of developing T1D, as indicated by specific genetic markers. Participants will be assigned to either a group receiving the dietary and activity counseling or a control group. They will have regular visits to the research clinic for check-ups, where their growth, blood samples, and feeding habits will be monitored. The study aims to gather important information that could help prevent T1D in children at risk, and families will be actively involved throughout this process.

Gender

ALL

Eligibility criteria

• 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.