NCT05899166
Carbohydrate Beta Cell Function and Glucose Control in Children With Diabetes
Recruiting
NAAges 5–12InterventionalTreatmentBoston Children's HospitalInvestigator-initiated
~52 participants
Updated 2025-04-24 on ClinicalTrials.gov
What's tested:Ketogenic diet, food delivery and educationStandard diet, food delivery and education
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Decline in Beta-cell Function
Measured over Change over 1, 5, and 9 months, corrected for baseline
Conditions
Where it's being run
1 sites across 1 statesMassachusetts1
Study leadership
- Belinda Lennerz · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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.
What this trial measures
- Decline in Beta-cell FunctionChange over 1, 5, and 9 months, corrected for baseline
Change in C-peptide 2-h area under the curve after a mixed-meal tolerance test (ΔCP).