Effects of a ketogenic diet on type 1 diabetes in children
Official title: Effect of Dietary Carbohydrate on Diabetes Control and Beta Cell Function in Children With Newly Diagnosed Diabetes
Run by Boston Children's Hospital · NCT05899166 · Data updated 2026-11-12
This study is testing if a ketogenic diet can help young children with newly diagnosed type 1 diabetes manage their condition better and stay healthy for longer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 5 Years to 12 Years |
| Sex | All |
| Enrollment | 52 (estimated) |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | May 31, 2024 |
| Main results expected | April 30, 2028 |
| Study ends | April 30, 2029 |
| Registry record updated | April 24, 2025 |
| Trial ID | NCT05899166 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 5 to 12 years who have been diagnosed with type 1 diabetes within the last three months.
✕Probably not a fit
Patients with dietary restrictions incompatible with the study meal plans, such as those following a vegan diet or with major food allergies, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the impact of a ketogenic diet on children aged 5 to 12 years who have recently been diagnosed with type 1 diabetes. The study aims to determine if a ketogenic diet can prolong the honeymoon period of diabetes, improve overall glucose control, and assess its safety and sustainability in this population. Participants will be randomly assigned to receive either a ketogenic or standard diet for 9 months, along with free meals, groceries, and intensive education on diabetes management. Data will be collected through continuous glucose monitoring and regular check-ins to evaluate dietary intake and satisfaction.
Why it matters
Potential benefit: If successful, this study could lead to improved management of type 1 diabetes in children, potentially extending the honeymoon period and enhancing overall glucose control.
How similar studies have gone: Preliminary data suggest that dietary interventions like the ketogenic diet may have positive effects on diabetes management, indicating potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Boston Children's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Belinda Lennerz — Boston Children's Hospital
- Study coordinator: Belinda Lennerz, MD PhD
- Email: belinda.lennerz@childrens.harvard.edu
- Phone: 857-218-3896
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.