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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

Attendance of at least 1 diabetes care visit over the past 12 months (including virtual)

Age 18 to 40 years

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 below

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I have attended a diabetes care appointment in the last year.

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I am between 18 and 40 years old.

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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

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

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 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Very low carbohydrate dietExperimental Treatment1 Intervention

Dietary Intervention, food delivery

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor

761 Previous Clinical Trials

5,579,718 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

Media Library

Very low carbohydrate diet Clinical Trial Eligibility Overview. Trial Name: NCT04200391 — N/A

Type 1 Diabetes Research Study Groups: Very low carbohydrate diet

Type 1 Diabetes Clinical Trial 2023: Very low carbohydrate diet Highlights & Side Effects. Trial Name: NCT04200391 — N/A

Very low carbohydrate diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT04200391 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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)."

Answered by AI

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)."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Very Low Carbohydrate Diets and Glucagon Response in T1DM

Belinda Lennerz 2020. "Very Low Carbohydrate Diets and Glucagon Response in T1DM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04200391.

All > Hypoglycemia