Actively Recruiting

Phase Not Applicable
Age: 5Years - 12Years
All Genders
NCT05899166

Carbohydrate Beta Cell Function and Glucose Control in Children With Diabetes

Led by Boston Children's Hospital · Updated on 2025-04-24

52

Participants Needed

1

Research Sites

256 weeks

Total Duration

On this page

Sponsors

B

Boston Children's Hospital

Lead Sponsor

U

University of South Florida

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Carbohydrate Beta Cell Function and Glucose Control in Children With Diabetes

Who Can Participate

Age: 5Years - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 5 to 12 years
  • Within 3 months of diabetes diagnosis
  • Insulin adjusted HbA1c C9 if enrolled C9 2 months past diagnosis
  • Type 1 diabetes confirmed by immediate insulin requirement and any 2 of the following: autoimmunity markers (glutamate decarboxylase-65, islet-antigen-2, zinc transporter-8, insulin prior to first insulin dose), age under 10 years, BMI less than 95th percentile
  • Family committed and able to participate in study education and implement dietary intervention
Not Eligible

You will not qualify if you...

  • Dietary needs or habits incompatible with 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

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Trial Site Locations

Total: 1 location

1

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

B

Belinda Lennerz, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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