32 Participants Needed

Very Low Carbohydrate Diet for Type 1 Diabetes

BL
SA
A
Overseen ByAzova
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Boston Children's Hospital
Must be taking: Insulin, Metformin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Despite major technological advances, management of type one diabetes mellitus (T1D) remains suboptimal, putting millions of people at risk for immediate and long-term complications. After meals, a mismatch between carbohydrate absorption rate and insulin action typically leads to alternating periods of hyper- and hypoglycemia. A conceptually promising approach to control both problems is dietary carbohydrate restriction to reduce postprandial blood glucose changes and insulin needs. In a prior survey study, the investigators documented exceptional glycemic control (HbA1c 5.67%) and low acute complication rates among 316 children and adults with T1D consuming a very-low-carbohydrate diet.To test the feasibility of this approach, the investigators will conduct a randomized-controlled feeding study involving 32 adults and adolescents with T1D. Participants will be randomized to receive a very low carbohydrate vs. standard carbohydrate diet. Participants will be in the study for 12 weeks and receive all their meals by meal delivery.They will share continuous glucose monitoring data with the study team and be in close communication to adjust insulin doses as needed. All participants will have a screening visit, an individual or group education session, and 3 study visits to evaluate diabetes control and metabolic health. Some of these visits will have a fasting blood draw. Two of the visits will also comprise additional metabolic studies to assess glucagon response and brain function during hypoglycemia by magnetic resonance imaging (MRI). Participants will have IV catheters placed and receive IV insulin to drop blood glucose levels to 50 mg/dl for up to 30 minutes. The primary outcome will be HbA1c change from baseline. Secondary outcomes include detailed measures of glycemic variability, metabolic health, and quality of life.

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 you cannot use medications other than insulin and metformin that could affect metabolic or glycemic variables. If you are on other medications, you might need to discuss this with the study team.

Is a very low carbohydrate diet safe for people with diabetes?

Research indicates that low-carbohydrate diets, including very low carbohydrate ketogenic diets, are generally safe for people with diabetes and can improve overall health, though concerns about safety remain. These diets have been shown to help with weight loss and may reduce the need for medication in some cases.12345

How does the Very Low Carbohydrate Diet treatment differ from other treatments for Type 1 diabetes?

The Very Low Carbohydrate Diet (VLCD) is unique because it focuses on significantly reducing carbohydrate intake, which can help manage blood sugar levels more effectively and potentially reduce the need for insulin. Unlike standard treatments that involve matching carbohydrate intake with insulin, this diet restricts carbs to about 75 grams per day, which may improve overall health and diabetes management.12456

What data supports the effectiveness of a very low carbohydrate diet as a treatment for Type 1 diabetes?

Research shows that low-carbohydrate diets can improve blood sugar control and overall health in people with diabetes, including Type 1. These diets can lead to reduced medication needs and better management of blood sugar levels without significant side effects.24578

Are You a Good Fit for This Trial?

Adults and adolescents aged 18-40 with Type 1 Diabetes, using an insulin pump and CGM, who have attended a diabetes care visit in the past year. They should not be on any restrictive diets or have conditions like celiac disease that affect diet.

Inclusion Criteria

Your blood sugar levels are under control and within a certain range.
You are currently using an insulin pump.
I have attended a diabetes care appointment in the last year.
See 4 more

Exclusion Criteria

You have a serious mental health condition.
I haven't had severe low blood sugar or ketoacidosis in the last 6 months.
You smoke, use drugs for fun, or drink too much alcohol.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Education

Participants attend an individual or group education session

1 week
1 visit (in-person)

Treatment

Participants receive a very low carbohydrate or standard carbohydrate diet for 12 weeks with continuous glucose monitoring and insulin dose adjustments

12 weeks
3 visits (in-person)

Metabolic Studies

Participants undergo metabolic studies including glucagon response and brain function assessment during hypoglycemia

During treatment phase
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Standard Carbohydrate Diet
  • Very Low Carbohydrate Diet
Trial Overview The trial is comparing the effects of a very low carbohydrate diet versus a standard one on blood sugar control in people with Type 1 Diabetes over 12 weeks. Participants will receive meal deliveries and undergo regular health checks including MRI scans.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: very low carbohydrate dietExperimental Treatment1 Intervention
Dietary Intervention, food delivery
Group II: standard dietActive Control1 Intervention
Dietary Intervention, food delivery

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+

Published Research Related to This Trial

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.
Low-carbohydrate diet in diabetes mellitus treatment.Krejčí, H., Vyjídák, J., Kohutiar, M.[2019]
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.
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]
Participants with Type 1 diabetes who followed a restricted carbohydrate diet (75 g/day) experienced challenges with insulin management, particularly mealtime insulin resistance, indicating that careful monitoring is needed during dietary transitions.
Both groups in the study felt more empowered in managing their diabetes after a carbohydrate counting course, but those on the restricted diet reported a significant impact on their mood and perception of food, suggesting the need for additional support from healthcare professionals.
From 'pleasure to chemistry': the experience of carbohydrate counting with and without carbohydrate restriction for people with Type 1 diabetes.Cresswell, P., Krebs, J., Gilmour, J., et al.[2019]

Citations

1.Czech Republicpubmed.ncbi.nlm.nih.gov
Low-carbohydrate diet in diabetes mellitus treatment. [2019]
Effect of a very low-carbohydrate ketogenic diet vs recommended diets in patients with type 2 diabetes: a meta-analysis. [2022]
From 'pleasure to chemistry': the experience of carbohydrate counting with and without carbohydrate restriction for people with Type 1 diabetes. [2019]
Dietary carbohydrate restriction as the first approach in diabetes management: critical review and evidence base. [2022]
Very low-carbohydrate diets in the management of diabetes revisited. [2017]
SUCCESSFUL REIMPLEMENTATION OF A VERY LOW CARBOHYDRATE KETOGENIC DIET AFTER SGLT2 INHIBITOR ASSOCIATED EUGLYCEMIC DIABETIC KETOACIDOSIS. [2022]
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]
A low-carbohydrate, ketogenic diet to treat type 2 diabetes. [2020]
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