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Very Low Carbohydrate Diet for Type 1 Diabetes
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Very low carbohydrate diet
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Is this investigation still accessible to participants?
"The clinical trial is open for enrollment, as indicated by the most recent update to its listing on clinicaltrials.gov, which occurred on November 17th 2022. This study was initially posted online in March of 2020."
What beneficial outcomes is the clinical trial hoping to bring about?
"This medical trial is assessing the efficacy of a very low carbohydrate diet over weeks 5-12, using Glucagon Treatment Success as its primary outcome. This success is measured by an increase in Plasma Glucose Level to ≥70mg/dL or an Increase of ≥20mg/dL From Glucose Nadir within 30 minutes after receiving 1 mg glucagon IM. Secondary goals include the measurement of Beta-Hydroxybutyrate and Glucose plasma levels following administration of glucagon, along with Recovery from Hypoglycemia Symptoms assessed via a scale ranging from 0 (not present) to 6 (very intense)."
To whom is this clinical experiment open for participation?
"The clinical trial seeks to enrol 12 persons, aged between 18 and 40 years old, with type 1 diabetes mellitus. Furthermore, these individuals must meet additional criteria: Tanner stage ≥ IV; a body mass index (BMI) ranging from 18.5-35 kg/m2; stable glycemic control (HbA1c 6.5-9%); utilisation of continuous glucose monitoring devices and insulin pumps; males and females who have had T1D for at least one year; attendance at one or more diabetes care visits in the last twelve months - including virtual ones)."
How many subjects are being evaluated in this clinical investigation?
"Affirmative. Clinicaltrials.gov reveals that this clinical trial is recruiting participants, having been first posted on 3rd January 2020 and most recently modified on 17th November 2022. In total, 12 patients are needed from a single facility."
Does this clinical trial accommodate those aged sixty-five and over?
"This clinical trial is only open to patients aged between 18 and 40. However, there are 155 studies available for minors and 178 trials designed specifically for seniors."
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