Ketogenic Diet for Type 1 Diabetes
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes those using medications other than insulin that could affect metabolism or blood sugar levels.
What data supports the effectiveness of the ketogenic diet treatment for type 1 diabetes?
Is the ketogenic diet safe for humans?
The ketogenic diet has been used for over 50 years and generally does not have major safety concerns for the general public. However, for people with type 1 diabetes, there may be an increased risk of hypoglycemia (low blood sugar) and dyslipidemia (abnormal blood fat levels), so caution is advised.16789
How is the ketogenic diet treatment different for type 1 diabetes?
The ketogenic diet is unique for type 1 diabetes as it focuses on high fat and low carbohydrates, which can improve blood sugar control but requires careful monitoring to avoid diabetic ketoacidosis (a dangerous condition caused by high levels of ketones). Unlike standard treatments that primarily involve insulin management, this diet alters the body's energy source, which can also help manage epilepsy in some patients.610111213
What is the purpose of this trial?
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.
Research Team
Belinda Lennerz, MD PhD
Principal Investigator
Boston Children's Hospital
Eligibility Criteria
This trial is for children aged 5-12 with newly diagnosed type 1 diabetes, confirmed by insulin requirement and autoimmunity markers. The family must be committed to participating in the study's education and dietary intervention.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a ketogenic or standard diet along with diabetes education and monitoring for 9 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ketogenic Diet
- Standard Diet
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Children's Hospital
Lead Sponsor
University of South Florida
Collaborator
Indiana University
Collaborator