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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up diet week 5-12
Awards & highlights
Study Summary
This trial will study the effects of a ketogenic diet on hypoglycemia tolerance and brain function in people with type 1 diabetes mellitus (T1D).
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.Check my eligibility
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.See study design
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.
Select...
My physical development is at an advanced stage.
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I have had Type 1 Diabetes for at least one year.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Glycemic threshold for hypothalamic activation
Secondary outcome measures
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 moreTrial 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
Find a Location
Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
761 Previous Clinical Trials
5,579,706 Total Patients Enrolled
Beth Israel Deaconess Medical CenterOTHER
837 Previous Clinical Trials
13,010,248 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How does one sign up for this clinical trial?
"Up to 24 patients who have ketosis and meet the age, BMI, and Tanner stage requirements may be admitted into this trial. Notably, all potential participants must have attended at least 1 diabetes care visit in the last year and use an insulin pump."
Answered by AI
How many people are eligible to participate in this research?
"Yes, you are correct. The clinical trial is currently recruiting patients and the information is displayed on clinicaltrials.gov. This particular trial was posted on 1/3/2020 and was last updated on 11/2/2021. They are enrolling a total of 24 patients at 1 site."
Answered by AI
Are researchers currently looking for participants in this clinical trial?
"The latest information from clinicaltrials.gov affirms that this study is still looking for patients. The posting went up on 1/3/2020 and the listing was updated as recently as 11/2/2021."
Answered by AI
For patients that are over the age of 70, is it possible to enroll in this particular clinical trial?
"This study is only for individuals who are young adults between 18 to 30 years old."
Answered by AI
Who else is applying?
What site did they apply to?
Boston Children's Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
1
0
What state do they live in?
Georgia
What questions have other patients asked about this trial?
How long the screening process would take?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I'VE TRIED JANUVIA MANY YEARS AGO. Hi, I want like to take part of this trial because the heavy condition of type 1 diabetes is what i live day and night from 7 years and to be part of a clinical trial on diabetes is very concerning for me, the everyday pain and frequent unbalances due to my very active life and addiction to sugar make me want to fight, learn more, understand more and help.
PatientReceived 1 prior treatment
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