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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 belowSelect...
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:Select...
I am not on medication that affects my metabolism or blood sugar, except for insulin or metformin.
Select...
I have anemia.
Select...
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
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 moreAwards & 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
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.
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.
Find a Location
Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
783 Previous Clinical Trials
5,581,257 Total Patients Enrolled
Beth Israel Deaconess Medical CenterOTHER
853 Previous Clinical Trials
12,929,925 Total Patients Enrolled
Belinda Lennerz, MD, PhDPrincipal Investigator - Boston Children's Hospital
Boston Children's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on medication that affects my metabolism or blood sugar, except for insulin or metformin.I am between 18 and 40 years old.You have a serious mental health condition.You have a history of problems with eating or are at risk for developing such problems, as determined by a specific scale.My physical development is at an advanced stage.I can have an MRI unless I'm on certain medications or have irregular periods.You are currently using a continuous glucose monitor.You smoke, use drugs for fun, or drink a lot of alcohol.I have anemia.I have had Type 1 Diabetes for at least one year.You are currently on a diet to lose weight or have other dietary restrictions.You use an insulin pump.Your body mass index (BMI) is between 18.5 and 35.You exercise really hard for more than 2 hours on more than 3 days a week.I haven't had severe low blood sugar or ketoacidosis in the last 6 months.Your blood sugar levels need to be within a certain range, as measured by the HbA1c test.
Research Study Groups:
This trial has the following groups:- Group 1: Standard diet
- Group 2: Very low carbohydrate diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Type 1 Diabetes Patient Testimony for trial: Trial Name: NCT04219709 — N/A
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