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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

Must not have

Major medical illness or use of medications other than insulin and metformin that could interfere with metabolic or glycemic variables

Ketoacidosis or severe hypoglycemia with seizure or coma in the past 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 5-12 on the very low carbohydrate diet

Awards & highlights

No Placebo-Only Group

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.

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.

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 am between 18 and 40 years old.

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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:

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I am not on medication that affects my metabolism or blood sugar, except for insulin or metformin.

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I haven't had severe low blood sugar or ketoacidosis in the last 6 months.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Plasma glucose levels following glucagon administration

Plasma levels of beta-hydroxybutyrate following glucagon administration

Plasma levels of free fatty acids following glucagon administration

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