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Very Low Carbohydrate Diet for Type 1 Diabetes

N/A

Waitlist Available

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of type 1 diabetes for at least 1 year

Insulin pump use for at least 2 months

Must not have

Current use of glucose-lowering agents other than insulin

BMI < 19 kg/m2 for individuals 18 years of age or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will help researchers understand how a very low carbohydrate diet impacts teens with type 1 diabetes, so that they can better understand the safety and efficacy of this diet for this population.

Who is the study for?

Adolescents with Type 1 Diabetes who can check blood ketones daily, use a continuous glucose monitor and insulin pump, and are willing to follow study diets. They must have an HbA1c level <10%, diagnosed for at least 1 year, and agree to effective contraception if applicable. Those on weight loss meds recently or with conditions affecting glucose metabolism or unstable psychiatric disorders cannot join.

What is being tested?

The trial is studying the effects of a very low carbohydrate diet compared to a standard one in young people with Type 1 Diabetes. It aims to understand how these diets affect metabolism and brain function, which will inform safe dietary advice for managing their condition.

What are the potential side effects?

While not explicitly listed, potential side effects may include changes in blood sugar levels that could lead to hypoglycemia or ketoacidosis due to the dietary intervention's impact on insulin requirements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with type 1 diabetes for over a year.

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I have been using an insulin pump for at least 2 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently using medication to lower my blood sugar, not including insulin.

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My BMI is less than 19.

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My BMI is below the 5th percentile for my age.

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I weigh less than 108 pounds.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Glucose

Secondary study objectives

Hyperglycemia

Time spent with hypoglycemia.

Other study objectives

Human Factors

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: low carbohydrate dietExperimental Treatment1 Intervention

In this crossover study, participants will be randomized to either a low or standard carbohydrate for 2 weeks. Participants in the low carbohydrate group will limit carbohydrate intake to 15% of total daily calories.

Group II: standard carbohydrate dietActive Control1 Intervention

In this crossover study, participants will be randomized to either a low or standard carbohydrate for 2 weeks. Participants in the standard carbohydrate group will follow an ad libitum diet with standard carbohydrate intake.

0 / 6Eligibility criteria met