NCT05899166 Carbohydrate Beta Cell Function and Glucose Control in Children With Diabetes
| NCT ID | NCT05899166 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Children's Hospital |
| Condition | Diabetes Mellitus, Type 1 |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2024-05-31 |
| Primary Completion | 2028-04-30 |
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 52 participants in total. It began in 2024-05-31 with a primary completion date of 2028-04-30.
⚠ 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 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 assess dietary intake, satisfaction with diet and study procedures, and possible safety concerns. * During four study visits held at at baseline, 1, 5, and 9 months, an intravenous catheter (IV) will be placed for collection of 5 blood samples before and up to 2 hours after a liquid test meal (protein shake) to assess insulin response. A stool sample will also be collected to assess microbiome changes. * Children and their caregivers may be invited to participate in a semi-structured interview, and online questionnaires to assess their experience with the diet and diabetes care, general well-being and quality of life. * Children and their caregivers may be invited to participate in a follow-up visit to evaluate long-term effects after 24 months. Comparison will be made between a ketogenic vs standard diet.
Eligibility Criteria
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 with metabolic or glycemic variables. * Major psychiatric illness.
Contact & Investigator
Belinda Lennerz
PRINCIPAL INVESTIGATOR
Boston Children's Hospital
Frequently Asked Questions
Who can join the NCT05899166 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 12 Years, studying Diabetes Mellitus, Type 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05899166 currently recruiting?
Yes, NCT05899166 is actively recruiting participants. Contact the research team at belinda.lennerz@childrens.harvard.edu for enrollment information.
Where is the NCT05899166 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05899166 clinical trial?
NCT05899166 is sponsored by Boston Children's Hospital. The principal investigator is Belinda Lennerz at Boston Children's Hospital. The trial plans to enroll 52 participants.
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