Ketogenic Diet for Type 1 Diabetes

Overseen By Belinda Lennerz, MD PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Must be taking: Insulin

Disqualifiers: Vegan, Eating disorders, Major illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 9 months

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a ketogenic diet affects children with newly diagnosed type 1 diabetes. Researchers aim to determine if this diet can extend the "honeymoon period" (a phase with easier diabetes control), improve overall diabetes management, and ensure safety. The study compares a ketogenic diet, high in protein and healthy fats, to a standard diet with more carbohydrates. It is open to children aged 5 to 12 who have been diagnosed with type 1 diabetes within the last three months and whose families are committed to making dietary changes. Participants will receive meal support, diabetes education, and regular check-ins for nine months. As an unphased trial, this study offers families a unique opportunity to contribute to groundbreaking research on dietary impacts in type 1 diabetes management.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that people with type 1 diabetes generally handle a ketogenic diet well. This diet can lower triglyceride levels—fats in the blood—more effectively than a low-fat diet.

One study examined the long-term safety of ketogenic diets and found they can be safe if they include essential nutrients like vitamins and minerals. However, monitoring for possible side effects, such as changes in cholesterol levels, is important. Some research in mice has suggested risks with very high-fat diets, but these results don't always apply to humans.

Overall, the ketogenic diet appears safe for most people when managed carefully. However, consulting a doctor before making significant dietary changes is always advisable, especially for children with type 1 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The ketogenic diet is unique for type 1 diabetes management because it drastically reduces carbohydrate intake, shifting the body's energy source from glucose to fats. This diet contrasts with the typical high-carb diet often recommended for diabetes, which includes a balanced mix of carbs, proteins, and fats. Researchers are excited about the ketogenic diet because it could offer better blood sugar control by minimizing carbohydrate-induced glucose spikes. Additionally, the increase in healthy fats and proteins might lead to more stable energy levels and potentially reduce the need for insulin.

What evidence suggests that a ketogenic diet might be an effective treatment for type 1 diabetes?

This trial will compare the effects of a ketogenic diet with a standard diet for managing type 1 diabetes. Research has shown that a ketogenic diet, which is very low in carbs and high in fats, might help manage type 1 diabetes. Studies have found that this diet can lead to better blood sugar control and improve insulin use in the body. Some participants on a ketogenic diet also showed lower triglyceride levels, which are fats in the blood. Additionally, evidence suggests this diet might reduce oxidative stress, which can harm cells. While more research is needed, these early findings offer hope for using a ketogenic diet in diabetes management. ^{1 3 6 7 8}

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 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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: ketogenic diet Experimental Treatment 1 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 diet Active Control 1 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.

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+

Published Research Related to This Trial

In a study of 26 individuals with type 1 diabetes, a high-monounsaturated-fat diet led to a 7% reduction in low-density lipoprotein (LDL) cholesterol, suggesting potential benefits for heart health.

For those who strictly adhered to the diet, significant improvements were observed, including an 18% reduction in total triglycerides and a 48% reduction in very low-density lipoprotein (VLDL) cholesterol, indicating a favorable change in the lipoprotein profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a high-monounsaturated-fat diet on lipid profile in subjects with type 1 diabetes. Strychar, I., Ishac, A., Rivard, M., et al.[2015]

Ketogenic diets, which consist of over 70% fat and very low carbohydrates, may be more effective than low-fat diets for treating obesity and diabetes, showing potential benefits in reducing blood glucose and insulin levels.

A well-formulated ketogenic diet appears to be safe for the general public and could be considered a first-line treatment for obesity and diabetes, although more high-quality clinical trials are needed to explore its long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Ketogenic Diet: Evidence for Optimism but High-Quality Research Needed. Ludwig, DS.[2023]

A 15-month follow-up of a 3.5-year-old girl with type 1 diabetes on a ketogenic diet (KD) showed no reported seizures despite persistent epileptiform activity on EEG, suggesting potential benefits of the KD in managing epilepsy.

The girl's glycosylated hemoglobin (HbA1c) levels improved significantly, indicating excellent glycemic control without severe side effects, demonstrating that the KD can be safely used in patients with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Type 1 diabetes and epilepsy: efficacy and safety of the ketogenic diet. Dressler, A., Reithofer, E., Trimmel-Schwahofer, P., et al.[2017]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-carbohydrate diets for type 1 diabetes mellitus: A systematic review. Turton, JL., Raab, R., Rooney, KB.[2022]

In a study of 1040 children with type 1 diabetes, 39% reported experience with low-carbohydrate diets, with 5.8% currently following one, indicating that such diets are not uncommon among this population.

Children on low-carbohydrate diets showed better glycemic control, with lower average blood sugar levels and more time spent in the target range, but there was also a tendency for increased episodes of hypoglycemia, suggesting a need for careful monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-Carbohydrate Diet among Children with Type 1 Diabetes: A Multi-Center Study. Neuman, V., Plachy, L., Pruhova, S., et al.[2022]

There is a noted association between type 1 diabetes and epilepsy, with potential mechanisms including genetic factors and metabolic issues, but the exact relationship remains unclear.

Current evidence is insufficient to recommend the ketogenic diet for children with both epilepsy and type 1 diabetes, highlighting the need for more research to assess its safety and efficacy in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intractable Seizures in Children With Type 1 Diabetes: Implications of the Ketogenic Diet. Vidmar, KK., Pollock, AJ.[2023]

In a study involving 89 participants with type 2 diabetes, a very low-calorie ketogenic (VLCK) diet led to significantly greater weight loss and improved glycemic control compared to a standard low-calorie diet over 4 months.

The VLCK diet was found to be safe and well-tolerated, with no serious adverse events reported and no significant changes in laboratory safety parameters, indicating it can be a viable option for managing obesity in T2DM patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Goday, A., Bellido, D., Sajoux, I., et al.[2022]

The ketogenic diet can be successfully implemented in a child with both epilepsy and type 1 diabetes, despite the challenges in distinguishing between diet-induced ketosis and diabetic ketoacidosis.

This case highlights the potential for the ketogenic diet to manage myoclonic astatic epilepsy while also addressing the child's diabetes, suggesting a dual benefit in carefully monitored settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ketogenic diet for the treatment of myoclonic astatic epilepsy in a child with type 1 diabetes mellitus. Aylward, NM., Shah, N., Sellers, EA.[2017]

The ketogenic diet (KD) is considered a relatively safe treatment for refractory childhood epilepsy, with severe adverse effects occurring in less than 0.5% of children, and no deaths attributed to the diet.

Common adverse effects include gastrointestinal disturbances and hyperlipidemia, but the main reason for discontinuation of the diet was lack of efficacy rather than safety concerns, highlighting the need for careful medical supervision during its implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of the ketogenic diet used for the treatment of refractory childhood epilepsy: a systematic review of published prospective studies. Cai, QY., Zhou, ZJ., Luo, R., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing type 1 diabetes mellitus with a ketogenic diet. Gardemann, C., Knowles, S., Marquardt, T.[2023]

A low-carbohydrate, high-fat ketogenic diet (KD) was effective in improving glycemic control in two type 2 diabetic patients over a 12-week period, with both patients showing significant reductions in HBA1C levels (2.4% and 2.5%).

The female patient was able to reduce her diabetic medication by 75%, while the male patient eliminated all diabetic medications, highlighting the potential of KDs as a viable dietary strategy for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Rallis, S.[2020]

A 42-year-old woman with type 2 diabetes experienced euglycemic diabetic ketoacidosis (euDKA) after starting a sodium-glucose co-transporter 2 (SGLT2) inhibitor while on a very low carbohydrate ketogenic diet (VLCKD), highlighting the risk of this combination.

After recovering from euDKA and stopping the SGLT2 inhibitor, she successfully resumed a VLCKD under medical supervision and maintained ketosis safely for 2 years, demonstrating that with proper monitoring, VLCKD can be safely reimplemented post-euDKA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SUCCESSFUL REIMPLEMENTATION OF A VERY LOW CARBOHYDRATE KETOGENIC DIET AFTER SGLT2 INHIBITOR ASSOCIATED EUGLYCEMIC DIABETIC KETOACIDOSIS. Fieger, EI., Fadel, KM., Modarres, AH., et al.[2022]

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