NCT06670625 Intensive Dietary and Activity Counselling (IDAC)
| NCT ID | NCT06670625 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lund University |
| Condition | Type 1 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,244 participants |
| Start Date | 2025-03-15 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,244 participants in total. It began in 2025-03-15 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 Diet and Activity Counseling (IDAC) from age 3 months to age 2 years improves beta-cell health in children with increased risk for islet autoimmunity. Secondary objectives are to determine whether IDAC is associated with infant and early childhood growth and body composition and to determine whether IDAC reduces the cumulative incidence of islet autoantibodies or type 1 diabetes in childhood. Participants will be randomized (ratio 1:1) to control group and intervention group. Breastfeeding status at time of randomization will be taken into account. Participants will be enrolled by the age of four months and visit the research clinic ever third months up until the age of 24 months, and then yearly up until the age of 6 years. * Anthropometric measurements and blood draw will be taken at each visit. * Questionnaires focusing on breastfeeding and early infant feeding habits will be used at each visit. * 24hrs recalls will be done at the age of 6, 9, 12, 18 and 24 months of age. * Physical activity will be estimated using questionnaires (3, 6, 9 months) and accelerometer data (12, 18 and 24 months). * Stool samples will be collected at 6, 12 and 18 months of age
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.
Contact & Investigator
Helena Elding Larsson, PhD
PRINCIPAL INVESTIGATOR
Lund University
Frequently Asked Questions
Who can join the NCT06670625 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, up to 4 Months, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06670625 currently recruiting?
Yes, NCT06670625 is actively recruiting participants. Contact the research team at carin.andren_aronsson@med.lu.se for enrollment information.
Where is the NCT06670625 trial being conducted?
This trial is being conducted at Malmö, Sweden.
Who is sponsoring the NCT06670625 clinical trial?
NCT06670625 is sponsored by Lund University. The principal investigator is Helena Elding Larsson, PhD at Lund University. The trial plans to enroll 1,244 participants.
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