RecruitingNot ApplicableNCT05899166

Carbohydrate Beta Cell Function and Glucose Control in Children With Diabetes

Effect of Dietary Carbohydrate on Diabetes Control and Beta Cell Function in Children With Newly Diagnosed Diabetes


Sponsor

Boston Children's Hospital

Enrollment

52 participants

Start Date

May 31, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 5 YearsMax Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a lower-carbohydrate diet can help preserve the body's remaining insulin-producing cells in children newly diagnosed with Type 1 diabetes, potentially allowing for better blood sugar control over time. **You may be eligible if...** - Your child is between 5 and 12 years old - Your child was diagnosed with Type 1 diabetes within the last 3 months - The diagnosis is confirmed by insulin requirement and at least 2 other markers (such as autoimmune markers, age under 10, or normal body weight) - Your family is able and willing to follow the study's dietary plan **You may NOT be eligible if...** - Your child has dietary restrictions incompatible with the study (e.g., vegan, major allergies) - Your child has an eating disorder - Your child has a major illness or takes medications other than insulin that could affect blood sugar - Your child has a significant psychiatric condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERKetogenic 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.

OTHERStandard 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.


Locations(1)

Boston Children's Hospital

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05899166


Related Trials