Ketogenic Diet for Type 1 Diabetes

Recruiting at 1 trial location

Overseen By Belinda Lennerz, MD PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

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

Compensation: Varies

Number of Visits: Unknown

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a very low carbohydrate diet (known as a ketogenic diet) can help individuals with type 1 diabetes manage low blood sugar more effectively and support brain function. Researchers aim to determine if using fat for energy instead of sugar can protect the brain during low blood sugar episodes. Participants will either maintain their usual diet or switch to this special low-carb diet. Individuals who have had type 1 diabetes for at least a year, use an insulin pump, and continuously monitor their blood sugar may be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative dietary approaches to improve 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 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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that very low carbohydrate diets, such as the ketogenic diet, can help people with type 1 diabetes manage their blood sugar. These diets may reduce blood sugar spikes after meals and improve overall blood sugar levels. They might also lower the risk of low blood sugar episodes, a concern for those with diabetes.

However, limited research exists on the long-term safety and effectiveness of these diets for people with type 1 diabetes. Some studies are short and yield varying results, making it difficult to draw clear conclusions. While some evidence suggests these diets can improve quality of life and insulin sensitivity, experts still debate their safety as an addition to insulin therapy.

In summary, very low carbohydrate diets seem promising for better blood sugar management, but more research is needed to fully understand their safety and long-term effects in type 1 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care for Type 1 diabetes, which typically involves insulin therapy and careful blood sugar monitoring, the very low carbohydrate (ketogenic) diet offers a different approach by significantly reducing carbohydrate intake. This diet is unique because it aims to stabilize blood sugar levels by minimizing the body's need for insulin. Researchers are excited about this treatment because it could potentially lead to better blood sugar control with fewer fluctuations, improving quality of life for people with Type 1 diabetes. Additionally, the ketogenic diet might help reduce the risk of long-term complications associated with diabetes by maintaining more consistent blood glucose levels.

What evidence suggests that this trial's treatments could be effective for type 1 diabetes?

This trial will compare a very low carbohydrate diet with a standard carbohydrate diet for managing type 1 diabetes. Studies have shown that a very low carbohydrate diet can improve blood sugar control in type 1 diabetes. Research indicates that individuals on this diet often achieve better long-term blood sugar levels, with HbA1c decreasing from 7.7% to 7.1%. This diet also reduces insulin requirements, helping to stabilize blood sugar levels. Additionally, it can lower the risk of low blood sugar episodes, which are common in diabetes. Improved insulin sensitivity, meaning the body uses insulin more effectively, was also observed. These findings suggest that a ketogenic diet might help people with type 1 diabetes manage their condition more effectively. ^{1 3 5 6 7}

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

My physical development is at an advanced stage.

You are currently using a continuous glucose monitor.

I have had Type 1 Diabetes for at least one year.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Standard carbohydrate diet
• Very low carbohydrate diet

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.

How Is the Trial Designed?

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+

Beth Israel Deaconess Medical Center

Collaborator

Trials

872

Recruited

12,930,000+

Published Research Related to This Trial

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]

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 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]

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]

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]

Low-carbohydrate diets have shown positive results in treating diabetes, pre-diabetes, metabolic syndrome, and obesity, with evidence from randomized trials and meta-analyses indicating they are safe and effective for improving health outcomes in diabetic patients.

These diets can lead to significant benefits such as weight loss, reduced medication needs, and even remission in some cases of type 2 diabetes, although they are not yet widely recognized in Czech diabetology due to ongoing safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-carbohydrate diet in diabetes mellitus treatment. Krejčí, H., Vyjídák, J., Kohutiar, M.[2019]

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]

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]

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 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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40573112/

Low-Carb and Ketogenic Diets in Type 1 Diabetes In general, carbohydrate restriction enhances glycemic control by reducing postprandial glucose excursions, improving time-in-range, and ...

2. mdpi.com mdpi.com/2072-6643/17/12/2001

Low-Carb and Ketogenic Diets in Type 1 Diabetes Except for lipids, though, multiple aspects of glycaemic control were improved: mean HbA1c was reduced from 7.7% to 7.1%, mean insulin units were decreased from ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2405457725001007

Low-carbohydrate diet in type 1 diabetes: A systematic ... Meta-analysis of studies included in this systematic review demonstrated that carbohydrate-restricted diets were more effective in improving some parameters of ...

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0288440

Effects of a low-carbohydrate diet in adults with type 1 ... Collectively, the data suggests that LC diet may reduce hypoglycaemia and improve quality of life in individuals with T1D; however, further well ...

5. diabetesjournals.org diabetesjournals.org/spectrum/article/33/2/133/32999/Low-Carbohydrate-and-Very-Low-Carbohydrate-Diets

Low-Carbohydrate and Very-Low-Carbohydrate Diets in ... Insulin sensitivity improved by 75% when measured via euglycemic-hyperinsulinemic clamp; mean A1C improved from 7.3 to 6.8% in 14 days. This ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12195831/

Low-Carb and Ketogenic Diets in Type 1 Diabetes In general, carbohydrate restriction enhances glycemic control by reducing postprandial glucose excursions, improving time-in-range, and lowering HbA1c.

7. ccjm.org ccjm.org/content/88/10/547

Ketogenic diets in the management of type 1 diabetes The jury is still out on whether a low-carbohydrate, ketosis-inducing diet is an effective and safe adjunctive therapy to insulin in type 1 diabetes.