Ketogenic Diet for Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests if a special low-carb diet or a ketone drink can help people with type 1 diabetes manage low blood sugar and improve brain function. The diet makes the body produce ketones, which the brain can use for energy when blood sugar is low. Researchers will compare brain activity during low blood sugar episodes in participants following the diet versus those who are not. The low-carbohydrate, ketogenic diet (LCKD) has been studied for its potential to improve blood sugar management and reduce medication use in diabetes care.
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 and metformin that could affect metabolism or blood sugar levels. If you are on other medications, you might need to discuss this with the trial team.
Is the ketogenic diet safe for people with type 1 diabetes?
The ketogenic diet may pose safety concerns for people with type 1 diabetes, such as the risk of diabetic ketoacidosis (a dangerous condition caused by high levels of ketones in the blood). In children, it may also affect growth and bone health. There are no established guidelines for safely following this diet in type 1 diabetes.12345
How is the ketogenic diet treatment different for type 1 diabetes?
The ketogenic diet is unique for type 1 diabetes as it focuses on a very low carbohydrate intake, which can improve blood sugar control without the need for increased medication. Unlike standard treatments that primarily rely on insulin, this diet may help manage blood sugar levels through dietary changes alone.16789
What data supports the effectiveness of the ketogenic diet treatment for type 1 diabetes?
Research shows that a ketogenic diet, which focuses on protein and healthy fats instead of carbohydrates, can lead to better blood sugar control and reduce insulin needs in people with type 1 diabetes. One study found that a patient on a ketogenic diet had significant improvements in diabetes-related health markers and required 70% less insulin.610111213
Who Is on the Research Team?
Belinda Lennerz, MD PhD
Principal Investigator
Boston Children's Hospital
Are You a Good Fit for This Trial?
This trial is for men and women aged 18-40 with Type 1 Diabetes Mellitus (T1D), who have had T1D for at least a year, use an insulin pump, and have stable blood sugar control. They should not be on any restrictive diets or have conditions like celiac disease or recent severe hypoglycemia.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dietary Intervention
Participants follow either a ketogenic diet or a standard carbohydrate diet for 12 weeks
Insulin Infusion and MRI Assessment
Participants undergo euglycemic-hypoglycemic insulin clamp and MRI to assess brain function and glycemic thresholds
Follow-up
Participants are monitored for safety and effectiveness after dietary intervention and assessments
What Are the Treatments Tested in This Trial?
Interventions
- Standard carbohydrate diet
- Very low carbohydrate diet
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Children's Hospital
Lead Sponsor
Beth Israel Deaconess Medical Center
Collaborator