Ketogenic Diet for Type 1 Diabetes

Recruiting at 1 trial location

Overseen by Belinda Lennerz, MD PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Boston Children's Hospital

Must be taking: Insulin, Metformin

Must not be taking: Psychotropics, Recreational drugs

Disqualifiers: Ketoacidosis, Severe hypoglycemia, others

No Placebo Group

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{2 7 11 12 13}

Research Team

Belinda Lennerz, MD PhD

Principal Investigator

Boston Children's Hospital

Eligibility Criteria

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

I am between 18 and 40 years old.

My physical development is at an advanced stage.

You are currently using a continuous glucose monitor.

Exclusion Criteria

I am not on medication that affects my metabolism or blood sugar, except for insulin or metformin.

You have a serious mental health condition.

Pregnancy or breastfeeding

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants follow either a ketogenic diet or a standard carbohydrate diet for 12 weeks

12 weeks

Weekly check-ins (virtual or in-person)

Insulin Infusion and MRI Assessment

Participants undergo euglycemic-hypoglycemic insulin clamp and MRI to assess brain function and glycemic thresholds

8 weeks

Multiple visits for MRI and infusion procedures

Follow-up

Participants are monitored for safety and effectiveness after dietary intervention and assessments

4 weeks

Treatment Details

Interventions

• Standard carbohydrate diet (Other)
• Very low carbohydrate diet (Other)

Trial Overview The study compares the effects of a very low carbohydrate (ketogenic) diet to a standard carbohydrate diet on brain function during low blood sugar episodes in people with T1D. It aims to understand if ketones can protect the brain when glucose levels drop.

Participant Groups

Group I: Very low carbohydrate diet Experimental Treatment 1 Intervention

Dietary Intervention, food delivery

Group II: Standard diet Active Control 1 Intervention

Dietary Intervention, food delivery

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Dr. Kevin B. Churchwell

Boston Children's Hospital

Chief Executive Officer since 2021

MD from Vanderbilt Medical School

Dr. Sarah Pitts

Boston Children's Hospital

Chief Medical Officer since 2019

MD from Harvard Medical School

Beth Israel Deaconess Medical Center

Collaborator

Trials

872

Recruited

12,930,000+

Dr. Kevin Tabb

Beth Israel Deaconess Medical Center

Chief Executive Officer since 2021

MD from Hebrew University Hadassah Medical School

Dr. Chi Chang Daniel Siao

Beth Israel Deaconess Medical Center

Chief Medical Officer since 2023

MD from King George’s Medical University

Findings from Research

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 16-week study involving 28 overweight participants with type 2 diabetes, the low-carbohydrate, ketogenic diet (LCKD) led to a significant 16% reduction in hemoglobin A1c levels, indicating improved glycemic control.

The diet also allowed for the discontinuation or reduction of diabetes medications in 17 out of 21 participants who completed the study, highlighting the need for close medical supervision when implementing such dietary changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A low-carbohydrate, ketogenic diet to treat type 2 diabetes. Yancy, WS., Foy, M., Chalecki, AM., et al.[2020]

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]

Participants with type 1 diabetes following a low carbohydrate diet (75 g per day) showed significant improvements in glycaemic control, with HbA1c levels decreasing from 63 to 55 mmol/mol (8.9% to 8.2%) and daily insulin use dropping from 64.4 to 44.2 units/day over 12 weeks.

The study suggests that a low carbohydrate diet can be a practical approach for managing type 1 diabetes, potentially reducing insulin requirements and aiding in weight loss, without negatively impacting other health markers like blood pressure or lipid profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised trial of the feasibility of a low carbohydrate diet vs standard carbohydrate counting in adults with type 1 diabetes taking body weight into account. Krebs, JD., Parry Strong, A., Cresswell, P., et al.[2022]

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]

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]

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]

A new clinical protocol was developed to safely monitor children with type 1 diabetes (T1D) on low-carbohydrate or ketogenic diets, focusing on key health parameters like growth, glycemic control, and bone health.

The protocol aims to ensure medical safety while accommodating families' dietary preferences, and its implementation will help establish informed guidelines for managing T1D in children on carbohydrate-restricted diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical management of children with type 1 diabetes on low-carbohydrate or ketogenic diets. Rydin, AA., Spiegel, G., Frohnert, BI., et al.[2023]

Ketogenic diets, which are low in carbohydrates and high in fats, have been shown to be effective for weight loss and can improve triglyceride and HDL cholesterol levels compared to low-fat diets.

Despite concerns about their high fat content, the degree of carbohydrate restriction needed to achieve ketosis is still unclear, indicating a need for more standardized research on these diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketogenic diets for weight loss: A review of their principles, safety and efficacy. Sumithran, P., Proietto, J.[2022]

The very low-carbohydrate ketogenic (VLCK) diet significantly improved glycemic control and resulted in greater weight loss compared to recommended diets for up to 6 months in people with type 2 diabetes, based on a meta-analysis of 8 randomized controlled trials involving 648 participants.

While the VLCK diet showed benefits in lowering triglycerides and increasing HDL cholesterol, its effectiveness in controlling diabetes and weight did not persist beyond 6 months, and adherence to the diet was a major challenge for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a very low-carbohydrate ketogenic diet vs recommended diets in patients with type 2 diabetes: a meta-analysis. Rafiullah, M., Musambil, M., David, SK.[2022]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Low-carbohydrate diets for type 1 diabetes mellitus: A systematic review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

A low-carbohydrate, ketogenic diet to treat type 2 diabetes. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Managing type 1 diabetes mellitus with a ketogenic diet. [2023]

4. China pubmed.ncbi.nlm.nih.gov

A randomised trial of the feasibility of a low carbohydrate diet vs standard carbohydrate counting in adults with type 1 diabetes taking body weight into account. [2022]

5. England 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. [2022]

6. England 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Intractable Seizures in Children With Type 1 Diabetes: Implications of the Ketogenic Diet. [2023]

8. Czech Republic pubmed.ncbi.nlm.nih.gov

Low-carbohydrate diet in diabetes mellitus treatment. [2019]

9. Denmark pubmed.ncbi.nlm.nih.gov

Medical management of children with type 1 diabetes on low-carbohydrate or ketogenic diets. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Ketogenic diets for weight loss: A review of their principles, safety and efficacy. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Effect of a very low-carbohydrate ketogenic diet vs recommended diets in patients with type 2 diabetes: a meta-analysis. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Type 1 diabetes and epilepsy: efficacy and safety of the ketogenic diet. [2017]

13. United States pubmed.ncbi.nlm.nih.gov

SUCCESSFUL REIMPLEMENTATION OF A VERY LOW CARBOHYDRATE KETOGENIC DIET AFTER SGLT2 INHIBITOR ASSOCIATED EUGLYCEMIC DIABETIC KETOACIDOSIS. [2022]