Carbohydrate Beta Cell Function and Glucose Control in Children With Diabetes
The goal of this clinical trial is to test the effects of a ketogenic diet on the progression and control of type 1 diabetes in children with newly diagnosed diabetes. The main questions to answer are: * Does a ketogenic diet prolong the honeymoon period of type 1 diabetes? * Does a ketogenic diet improve diabetes cont
| Condition(s) | Diabetes Mellitus, Type 1 |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The goal of this clinical trial is to test the effects of a ketogenic diet on the progression and control of type 1 diabetes in children with newly diagnosed diabetes. The main questions to answer are: * Does a ketogenic diet prolong the honeymoon period of type 1 diabetes? * Does a ketogenic diet improve diabetes control? * Is a ketogenic diet safe, acceptable and sustainable in children with newly diagnosed diabetes? * What are the microbiome, inflammatory and metabolic changes linking diet to β-cell function? Participants will receive a combination of free meals, groceries, micronutrient supplements, and intensive diet and diabetes education for 9 months. * Diabetes care devices will be connected for cloud-based data collection. * Bi-weekly data downloads and remote check-ins will asses |
| Who can participate | Inclusion Criteria: * Children aged 5 to 12 years. * Within 3 month of diabetes diagnosis. * Insulin adjusted HbA1c ≤9 if enrolled ≥ 2 months pat diagnosis. * Type 1 diabetes confirmed by immediate insulin requirement and any 2 of the following criteria: autoimmunity marker \[glutamate decarboxylase-65, islet-antigen-2, zinc transporter-8, insulin \[prior to first insulin dose\]; age under 10 years, BMI \<95th percentile. * Family committed and able to participate in study education and implement dietary intervention. Exclusion Criteria: * Dietary needs or habits incompatible with the study meal plans, (e.g., vegan, major food intolerances/allergies, ketogenic). * Eating disorders as assessed by Chede-Q8. * Major medical illness or use of medications other than insulin that could interfere |
| Ages | 5 Years to 12 Years |
| Sex | All |
| Lead sponsor | Boston Children's Hospital |
| Locations | Boston, Massachusetts, United States |
| Start date | 2024-05-31 |
| NCT ID | NCT05899166 |
| Official listing | https://clinicaltrials.gov/study/NCT05899166 |