Intensive dietary and activity counseling for children at risk of Type 1 Diabetes
Intensive Dietary and Activity Counselling
This study tests whether giving intensive diet and activity counseling to infants at high risk for Type 1 Diabetes can help them stay healthier and reduce their chances of developing diabetes-related issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1244 (estimated) |
| Ages | 3 Months to 4 Months |
| Sex | All |
| Sponsor | Lund University Academic / other |
| Locations | 1 site (Malmö) |
| Trial ID | NCT06670625 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are infants aged 3 months with a genetic predisposition to Type 1 Diabetes.
Not a fit: Patients without a genetic risk for Type 1 Diabetes or those with existing medical conditions that interfere with the study may not benefit.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of developing Type 1 Diabetes in genetically predisposed children.
How similar studies have performed: Previous studies have indicated a link between early lifestyle factors and the risk of Type 1 Diabetes, suggesting that this approach may hold promise.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Malmö
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.