Ketogenic Diet for Type 1 Diabetes

Recruiting at 1 trial location

Overseen By Tara Wilmot, RDN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must be taking: Insulin

Must not be taking: SGLT2 inhibitors

Disqualifiers: Gastroparesis, Hypertension, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

58 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a very-low-carbohydrate ketogenic diet (a high-fat, low-carb diet) can help people with type 1 diabetes manage their blood sugar levels more effectively and safely. Participants will either follow the ketogenic diet or adhere to the standard care diet recommended by the American Diabetes Association. Individuals who have had type 1 diabetes for more than a year, use insulin pumps or injections, and are not currently on a low-carb diet may be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore innovative dietary approaches for managing type 1 diabetes.

Do I have to stop taking my current medications for the trial?

Yes, you must stop taking diabetes medications other than insulin, especially SGLT2 inhibitors. The protocol does not specify a washout period.

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

Research has shown that ketogenic diets, which are very low in carbohydrates, have been studied for their safety and effectiveness in managing type 1 diabetes. One study found that people on a ketogenic diet had lower triglyceride levels (a type of fat in the blood) compared to those on a low-fat diet, suggesting potential heart health benefits for people with diabetes.

Another study discovered that a ketogenic diet increased feelings of satisfaction and fullness by focusing on proteins and fats instead of carbs. This can be encouraging for those concerned about feeling deprived or hungry.

While these findings indicate that the ketogenic diet can be well-tolerated, individual experiences may vary. Consulting healthcare providers before making major dietary changes is crucial, especially when managing a condition like type 1 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The ketogenic diet is unique because it offers a new approach to managing type 1 diabetes through dietary means, rather than medication. While standard care typically involves insulin therapy and a balanced diet high in non-starchy vegetables and lean proteins, the ketogenic diet focuses on a very low carbohydrate intake, which can lead to reduced blood sugar levels and potentially lower insulin requirements. Researchers are excited about this treatment because it could provide better blood sugar control and minimize the risk of hypoglycemia, offering a promising alternative to traditional dietary guidelines.

What evidence suggests that the Ketogenic Diet might be an effective treatment for type 1 diabetes?

Research has shown that ketogenic diets, which are very low in carbohydrates, can help manage type 1 diabetes. In this trial, participants in the Ketogenic Diet arm will consume a very-low carbohydrate diet (less than 50 grams per day) for 12 weeks. One study found that people on a ketogenic diet experienced a greater reduction in blood fats (triglycerides) compared to those on a low-fat diet. Another study found that a ketogenic diet can improve blood sugar control by reducing carb intake to less than 50 grams a day. This lower amount of carbs helps maintain steady blood sugar levels and may lower the risk of diabetes complications. Overall, these findings suggest that a ketogenic diet could effectively improve blood sugar control in type 1 diabetes. ^{2 6 7 8 9}

Who Is on the Research Team?

Samuel Klein, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

Adults with type 1 diabetes who struggle to maintain recommended blood sugar levels are eligible for this trial. Specific eligibility criteria have not been provided, but typically participants must meet certain health standards and may be required to adhere to specific dietary guidelines.

Inclusion Criteria

eGFR ≥60 mL/min/1.73 m2

I use an insulin pump or take multiple insulin injections daily.

Use of cellular phone with data capability for wireless connectivity to the CGM system.

Exclusion Criteria

I am able to understand and agree to the study on my own.

Anemia (Hgb <10 g/dL)

Major psychiatric illness

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a 12-week dietary intervention with either a ketogenic diet or a standard care diet

12 weeks

Weekly check-ins (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ketogenic Diet

Trial Overview

This study is testing if a ketogenic diet, which is very low in carbohydrates, can help adults with type 1 diabetes control their blood sugar better than a standard diet. Participants will be randomly assigned to one of the two diets.

How Is the Trial Designed?

Group I: Ketogenic Diet Experimental Treatment 1 Intervention

The Ketogenic Diet group will consume a very-low carbohydrate diet (\<50 g/day) diet. Participants will receive isocaloric packed-out meals for 12 weeks.

Group II: Standard Care Active Control 1 Intervention

The Standard Care group will consume a diet consistent with the guidelines recommended by the American Diabetes Association that is high in non-starchy vegetables and lean protein sources and low in added sugar. Participants will receive isocaloric packed-out meals for 12 weeks.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

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 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]

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 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]

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 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]

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]

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]

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]

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]

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]

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