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Ketogenic Diet for Type 1 Diabetes

N/A

Recruiting

Led By Samuel Klein, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

Use of an insulin pump or insulin delivery by multiple daily injections

Age ≥18 and ≤65 years

Must not have

Persons who are not able to grant voluntary informed consent

Poorly controlled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after the dietary intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a very-low-carbohydrate ketogenic diet can help adults with type 1 diabetes better control their blood sugar levels, even though most people with type 1 diabetes struggle to reach

Who is the study for?

Adults with type 1 diabetes who struggle to maintain recommended blood sugar levels are eligible for this trial. Specific eligibility criteria have not been provided, but typically participants must meet certain health standards and may be required to adhere to specific dietary guidelines.

What is being tested?

This study is testing if a ketogenic diet, which is very low in carbohydrates, can help adults with type 1 diabetes control their blood sugar better than a standard diet. Participants will be randomly assigned to one of the two diets.

What are the potential side effects?

Potential side effects from a ketogenic diet might include nutritional deficiencies, constipation or diarrhea, low energy levels initially (keto flu), and possible changes in cholesterol levels.

Eligibility Criteria

Inclusion Criteria

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

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I use an insulin pump or take multiple insulin injections daily.

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I am between 18 and 65 years old.

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I have been on a consistent insulin regimen for the last 30 days.

Exclusion Criteria

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

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I am able to understand and agree to the study on my own.

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My blood pressure is not well controlled, being 160/100 mmHg or higher.

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I have severe stomach emptying issues or have had weight loss surgery.

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I have been hospitalized for diabetes issues within the last year.

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I have been diagnosed with familial hypercholesterolemia.

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I do not have severe heart, lung, kidney, or liver disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before and immediately after the dietary intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before and immediately after the dietary intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and before and immediately after the dietary intervention for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in continuous glucose monitor (CGM) time-in-range

Change in skeletal muscle insulin sensitivity

Secondary study objectives

Adaptations needed to implement the diet at the population level

Change in 24-hour glucagon concentrations

Change in 24-hour glucose concentrations

+23 more

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: Ketogenic DietExperimental Treatment1 Intervention

The Ketogenic Diet group will consume a very-low carbohydrate diet (\<50 g/day) diet. Participants will receive isocaloric packed-out meals for 26 weeks.

Group II: Standard CareActive Control1 Intervention

The Standard Care group will consume a diet consistent with the guidelines recommended by the American Diabetes Association that is high in non-starchy vegetables and lean protein sources and low in added sugar. Participants will receive isocaloric packed-out meals for 26 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketogenic Diet

2016

Completed Phase 2

~460

0 / 9Eligibility criteria met