52 Participants Needed

Ketogenic Diet for Type 1 Diabetes

BL
Overseen ByBelinda Lennerz, MD PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Boston Children's Hospital
Must be taking: Insulin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Research shows that a ketogenic diet, which is low in carbohydrates and high in fats, can improve blood sugar control in people with type 1 diabetes. One study found that a patient on this diet had significant improvements in diabetes-related health markers and reduced insulin needs by 70%.12345

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

BL

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

My family and I can join in the study's education and follow its diet plan.
My child is between 5 and 12 years old.
Within one month of diabetes diagnosis
See 1 more

Exclusion Criteria

Eating disorders as assessed by Chede-Q8
Dietary needs or habits incompatible with the study meal plans (e.g., vegan, major food intolerances/allergies, ketogenic)
Major psychiatric illness
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a ketogenic or standard diet along with diabetes education and monitoring for 9 months

9 months
Bi-weekly remote check-ins, 5 in-person visits at baseline, 1, 5, 9, and 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 months
In-person visits at 9 and 24 months

Treatment Details

Interventions

  • Ketogenic Diet
  • Standard Diet
Trial Overview The trial tests if a ketogenic diet can extend the 'honeymoon' period of type 1 diabetes, improve control over it, and assess its safety and sustainability. It involves free meals, supplements, education, regular check-ins, blood sample collection after a test meal, stool samples for microbiome analysis.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: ketogenic dietExperimental Treatment1 Intervention
The diet will be high in protein and healthy fats and comprise meat, fish, fibrous vegetables, nuts, dairy, and berries. Macronutrient composition will be \~ 5% carbohydrate, 20% protein, 70% fat. Participants will receive a daily multi-vitamin, magnesium supplement, and supplemental salt (bouillon cubes) to ascertain micronutrient sufficiency and help with transition to the diet.
Group II: standard dietActive Control1 Intervention
The diet will be consistent with prevailing dietary guidelines and recommendations and contain meat, fish, grains, vegetables, fruit and dairy. At least 50% of grain-based products will be whole grains. Meats will be primarily lean, and dairy products will be fat-free or low-fat. Macronutrient composition will be \~50% carbohydrate (\<10% added sugars), 20% protein, 30% fat. Participants will receive a daily multi-vitamin supplement to ascertain micronutrient sufficiency.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+

University of South Florida

Collaborator

Trials
433
Recruited
198,000+

Indiana University

Collaborator

Trials
1,063
Recruited
1,182,000+

Findings from Research

In a study of 11 adults with Type 1 diabetes following a ketogenic diet for an average of 2.6 years, participants achieved excellent glycaemic control with a mean HbA1c of 5.3%, indicating effective blood sugar management.
However, while the diet improved glycaemic control, it was also linked to dyslipidaemia, with high cholesterol levels in many participants, and a notable occurrence of hypoglycaemic episodes, suggesting potential health risks that need monitoring.
The glycaemic benefits of a very-low-carbohydrate ketogenic diet in adults with Type 1 diabetes mellitus may be opposed by increased hypoglycaemia risk and dyslipidaemia.Leow, ZZX., Guelfi, KJ., Davis, EA., et al.[2022]
A systematic review of nine studies on low-carbohydrate diets for managing type 1 diabetes found that while some studies reported significant reductions in HbA1c, the overall effect was inconclusive due to significant variability among the studies.
The review highlights the need for more rigorous primary studies to better understand the impact of low-carbohydrate diets on diabetes management, as current evidence is limited and mixed.
Low-carbohydrate diets for type 1 diabetes mellitus: A systematic review.Turton, JL., Raab, R., Rooney, KB.[2022]
A ketogenic diet significantly improved diabetes-related biomarkers in a male type 1 diabetic patient, bringing them into the non-diabetic range and reducing total daily insulin requirements by 70%.
The patient reported a substantial enhancement in quality of life, suggesting that dietary changes can have positive health outcomes for individuals with type 1 diabetes.
Managing type 1 diabetes mellitus with a ketogenic diet.Gardemann, C., Knowles, S., Marquardt, T.[2023]

References

The glycaemic benefits of a very-low-carbohydrate ketogenic diet in adults with Type 1 diabetes mellitus may be opposed by increased hypoglycaemia risk and dyslipidaemia. [2022]
Low-carbohydrate diets for type 1 diabetes mellitus: A systematic review. [2022]
Managing type 1 diabetes mellitus with a ketogenic diet. [2023]
Low-Carbohydrate Diet among Children with Type 1 Diabetes: A Multi-Center Study. [2022]
Optimizing glycemic control in type 2 diabetic patients through the use of a low-carbohydrate, high-fat, ketogenic diet: a review of two patients in primary care. [2020]
Intractable Seizures in Children With Type 1 Diabetes: Implications of the Ketogenic Diet. [2023]
Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional weight loss program versus hypocaloric diet in patients with type 2 diabetes mellitus. [2022]
The Ketogenic Diet: Evidence for Optimism but High-Quality Research Needed. [2023]
Safety and tolerability of the ketogenic diet used for the treatment of refractory childhood epilepsy: a systematic review of published prospective studies. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Type 1 diabetes and epilepsy: efficacy and safety of the ketogenic diet. [2017]
11.United Statespubmed.ncbi.nlm.nih.gov
Impact of a high-monounsaturated-fat diet on lipid profile in subjects with type 1 diabetes. [2015]
12.United Statespubmed.ncbi.nlm.nih.gov
SUCCESSFUL REIMPLEMENTATION OF A VERY LOW CARBOHYDRATE KETOGENIC DIET AFTER SGLT2 INHIBITOR ASSOCIATED EUGLYCEMIC DIABETIC KETOACIDOSIS. [2022]
The ketogenic diet for the treatment of myoclonic astatic epilepsy in a child with type 1 diabetes mellitus. [2017]
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