What is the mechanism of action of this treatment?

The most common treatment for Type 1 Diabetes (T1D) is insulin therapy, which replaces the insulin that the pancreas no longer produces, helping to regulate blood glucose levels and prevent hyperglycemia. Another treatment being studied is the ketogenic diet, which is low in carbohydrates and induces a state of nutritional ketosis. In this state, the body produces ketone bodies from fat, providing an alternative fuel source for the brain. This can stabilize blood glucose levels and improve cognitive function during hypoglycemic episodes. Understanding these mechanisms is crucial for T1D patients to manage their condition effectively and minimize complications.

What side effects are associated with this type of intervention?

Common treatments for Type 1 Diabetes include insulin therapy and dietary interventions like the ketogenic diet. Insulin therapy can lead to hypoglycemia, weight gain, and, in some cases, diabetic ketoacidosis (DKA) if not managed properly. The ketogenic diet, which promotes the production of ketone bodies as an alternative brain fuel, may cause side effects such as constipation, headache, halitosis, muscle cramps, diarrhea, general weakness, and rash. Both treatments require careful monitoring to minimize adverse effects and ensure effective glycemic control.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Type 1 Diabetes that focus on producing ketone bodies as an alternative brain fuel similar to the ketogenic diet. Most FDA-approved treatments for T1D focus on insulin therapy to manage blood glucose levels. However, the concept of using ketone bodies as an alternative brain fuel during hypoglycemia is being studied, and no mechanistic studies or trials have yet explored this potential treatment approach for T1D.

What other types of research exist?

Promising novel alternatives to the ketogenic diet for T1D patients include: 1) Continuous insulin delivery systems, particularly hybrid closed-loop (HCL) systems, which improve glycemic control and quality of life. 2) Adjunctive therapies such as pramlintide, which can help manage blood glucose levels when used alongside insulin. 3) Low carbohydrate diets (LCDs) that are less restrictive than ketogenic diets but still help in managing blood glucose levels effectively. These alternatives offer potential benefits in glycemic control and overall diabetes management.

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Ketogenic Diet for Type 1 Diabetes

N/A

Recruiting

Led By Belinda Lennerz, MD, PhD

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 to 40 years

Tanner stage ≥ IV

Must not have

Major medical illness or use of medications other than insulin and metformin that could interfere with metabolic or glycemic variables

Anemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up diet week 5-12

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include digestive changes due to dietary adjustments, possible nutrient deficiencies from restricted food groups, and symptoms related to shifts in metabolism as the body adapts to using ketones for energy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 40 years old.

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My physical development is at an advanced stage.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have anemia.

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I haven't had severe low blood sugar or ketoacidosis in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ diet week 5-12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~diet week 5-12

This trial's timeline: 3 weeks for screening, Varies for treatment, and diet week 5-12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Glycemic threshold for hypothalamic activation

Secondary study objectives

Blood glucose level at which participant reports symptoms of hypoglycemia.

Cognitive performance during hypoglycemia

Functional connectivity changes in brain areas related to cognition during hypoglycemia

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatment for Type 1 Diabetes (T1D) is insulin therapy, which replaces the insulin that the pancreas no longer produces, helping to regulate blood glucose levels and prevent hyperglycemia. Another treatment being studied is the ketogenic diet, which is low in carbohydrates and induces a state of nutritional ketosis. In this state, the body produces ketone bodies from fat, providing an alternative fuel source for the brain. This can stabilize blood glucose levels and improve cognitive function during hypoglycemic episodes. Understanding these mechanisms is crucial for T1D patients to manage their condition effectively and minimize complications.

Medical management of children with type 1 diabetes on low-carbohydrate or ketogenic diets.Carbohydrate Restriction in Type 1 Diabetes: A Realistic Therapy for Improved Glycaemic Control and Athletic Performance?Moving beyond subcutaneous insulin: the application of adjunctive therapies to the treatment of type 1 diabetes.