Carbohydrate Beta Cell Function and Glucose Control in Children With Diabetes

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

OTHER

Ketogenic diet, food delivery and education

Meals and groceries will be delivered and participants will receive education on nutrition, meal preparation, and diabetes care strategies. Participants will consume study-prescribed foods exclusively.

OTHER

Standard diet, food delivery and education

Meals and groceries will be delivered and participants will receive education on nutrition, meal preparation, and diabetes care strategies. Participants will consume study-prescribed foods exclusively.

Sponsors & Collaborators

• University of South Florida

  collaborator OTHER

• Indiana University

  collaborator OTHER

• Boston Children's Hospital

  lead OTHER

Principal Investigators

• Belinda Lennerz · Boston Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-31

Primary Completion

2028-04-30

Completion

2029-04-30

Countries

• United States

Study Locations