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Very Low Carbohydrate Diet for Type 1 Diabetes
N/A
Recruiting
Led By Belinda Lennerz
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
Males and females with T1D for at least 1 year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 5-12 on the very low carbohydrate diet
Awards & highlights
Study Summary
This trial will study whether a very-low-carbohydrate diet results in an adequate response to glucagon in young adults with type 1 diabetes.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include risks associated with very low carbohydrate intake such as nutrient deficiencies if not properly managed. The intervention could also affect how the body responds to glucagon when blood sugar is low after prolonged carbohydrate restriction.
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...
I have had Type 1 Diabetes for at least one year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 5-12 on the very low carbohydrate diet
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 5-12 on the very low carbohydrate diet
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Glucagon treatment success, defined as an increase in glucose level to ≥ 70 mg/dL or an Increase of ≥ 20 mg/dL from glucose nadir within 30 minutes after receiving 1 mg glucagon IM
Secondary outcome measures
Plasma glucose levels following glucagon administration
Plasma levels of beta-hydroxybutyrate following glucagon administration
Plasma levels of free fatty acids following glucagon administration
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Very low carbohydrate dietExperimental Treatment1 Intervention
Dietary Intervention, food delivery
Find a Location
Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
769 Previous Clinical Trials
5,580,517 Total Patients Enrolled
Belinda LennerzPrincipal Investigator - Boston Children's Hospital
Boston Children's Hospital
2 Previous Clinical Trials
392 Total Patients Enrolled
Belinda S LennerzPrincipal InvestigatorBoston Children's Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can have an MRI and don't use strong psychiatric drugs.You use a continuous glucose monitor (CGM).You do intense exercise for more than two hours, at least three days a week.You have a history of an eating disorder or are at risk for having one, as determined by a special test called the Eating Disorders Diagnostic Scale (EDDS).I am not on medication that affects my metabolism or blood sugar, except for insulin or metformin.You are currently on a diet to lose weight or restrict your food intake.I have attended a diabetes care appointment in the last year.Your body mass index (BMI) is between 18.5 and 35.You are currently using an insulin pump.I am between 18 and 40 years old.You are at least in the fourth stage of puberty.I have had Type 1 Diabetes for at least one year.I haven't had severe low blood sugar or ketoacidosis in the last 6 months.You have a serious mental health condition.Your blood sugar levels are within a specific range (HbA1c 6.5-9%).You are a regular smoker, use recreational drugs, or drink a lot of alcohol.I have anemia.
Research Study Groups:
This trial has the following groups:- Group 1: 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.
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