Very Low Carbohydrate Diet for Type 1 Diabetes

Overseen By Belinda S 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: 1

Duration: 12 weeks

12 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 diet can help manage blood sugar levels in people with type 1 diabetes. Researchers seek to understand how this diet affects the body's response to glucagon, a medication that raises blood sugar during severe drops. Participants will follow either a very low carbohydrate diet or a standard diet for 12 weeks. Young adults with type 1 diabetes who use an insulin pump and maintain stable blood sugar control might be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance dietary recommendations for managing type 1 diabetes.

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 mentions that participants can only use insulin and metformin. If you are on other medications, you might need to stop them to participate.

What prior data suggests that this very low carbohydrate diet is safe for type 1 diabetes?

In a previous study, a very low carbohydrate (VLC) diet helped people with type 1 diabetes (T1D) manage their blood sugar more effectively. Research has shown that this diet can lower blood sugar levels after meals and reduce the need for insulin. Specifically, one study found that insulin sensitivity improved by 75%, and average blood sugar levels (measured as A1C) dropped from 7.3% to 6.8% in just two weeks.

However, concerns exist regarding the safety of the VLC diet. Its restrictive nature might increase the risk of ketoacidosis (a serious condition where the body produces too many ketones) and hypoglycemia (low blood sugar). One small study with 10 participants found that glucagon (a hormone that raises blood sugar) remained effective after a week on the diet. However, longer-term studies have not yet been conducted to fully understand these risks.

Overall, while the VLC diet may aid in blood sugar control, questions about its long-term safety remain. People considering this diet should carefully weigh the potential benefits and risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatment options for Type 1 Diabetes, which typically involve insulin therapy and careful blood sugar monitoring, a very low carbohydrate diet offers a unique approach by significantly reducing the intake of carbohydrates. This dietary intervention aims to stabilize blood sugar levels more naturally and may reduce the reliance on insulin. Researchers are excited about this treatment because it could offer a more holistic way to manage diabetes, potentially improving patients' quality of life by minimizing blood sugar fluctuations and reducing the risk of diabetes-related complications.

What evidence suggests that a very low carbohydrate diet is effective for type 1 diabetes?

Studies have shown that a very low carbohydrate (VLC) diet can help people with type 1 diabetes (T1D) manage their blood sugar levels more effectively. Research indicates that this diet reduces blood sugar spikes after meals and improves overall sugar control, often measured by the HbA1c test. One survey found that people following a VLC diet had an average HbA1c of 5.67%, which is excellent. Additionally, the VLC diet may lower the risk of low blood sugar episodes and improve quality of life. However, while these findings are promising, the diet's strict nature and potential risks are still under investigation. Participants in this trial will follow the VLC diet to further evaluate its effects on blood sugar management and overall health in individuals with T1D. ^{1 2 3 4 6}

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 adults aged 18-40 with Type 1 Diabetes who have been managing their condition for at least a year, attend regular diabetes care visits, and use a continuous glucose monitor and insulin pump. They should have a BMI of 18.5-35 kg/m2 and stable glycemic control. Those pregnant, on restrictive diets, with significant illnesses or psychiatric conditions, substance abuse issues, recent severe diabetic complications or certain dietary restrictions cannot participate.

Inclusion Criteria

You use a continuous glucose monitor (CGM).

I have attended a diabetes care appointment in the last year.

Your body mass index (BMI) is between 18.5 and 35.

Exclusion Criteria

Pregnancy or breastfeeding

I can have an MRI and don't use strong psychiatric drugs.

You do intense exercise for more than two hours, at least three days a week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a very low carbohydrate diet or a standard diet for 12 weeks

12 weeks

Weekly monitoring visits

Glucagon Challenge

Participants in the VLC arm undergo a glucagon challenge to assess glucagon response after dietary intervention

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Very low carbohydrate diet

Trial Overview

The study tests the effectiveness of a Very Low Carbohydrate Diet (VLC) in maintaining adequate glucagon response during hypoglycemia in people with Type 1 Diabetes over a longer term (12 weeks). Participants will be randomly assigned to either follow the VLC diet or standard diet and then undergo controlled testing involving induced low blood sugar followed by glucagon injection.

How Is the Trial Designed?

Group I: Very low carbohydrate diet Experimental Treatment 1 Intervention

Dietary Intervention, food delivery

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

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]

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]

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]

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 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]

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]

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 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]

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 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 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]

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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.