RecruitingNot ApplicableNCT06503809

Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes


Sponsor

Washington University School of Medicine

Enrollment

58 participants

Start Date

Aug 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Despite strong evidence that tight control of blood sugar reduces the risk of diabetes complications, most people with type 1 diabetes do not achieve recommended blood sugar targets. This randomized controlled trial will test whether a very-low- carbohydrate ketogenic diet can effectively and safely improve blood sugar control in adults with type 1 diabetes.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a ketogenic (very low-carbohydrate, high-fat) diet is safe and effective for adults with Type 1 diabetes. Researchers want to see how this diet affects blood sugar control compared to standard dietary recommendations. **You may be eligible if...** - You are 18–65 years old with Type 1 diabetes diagnosed more than 1 year ago - Your HbA1c (average blood sugar) is between 7.0% and 9.0% - You use an insulin pump or multiple daily insulin injections - You use a continuous glucose monitor (CGM) and have done so for at least 12 weeks - Your kidney function is adequate **You may NOT be eligible if...** - Your BMI is below 20 or above 34.9 - You have severe stomach emptying problems or have had weight-loss surgery - You have been hospitalized for diabetic emergencies in the last year - You have poorly controlled high blood pressure - You take diabetes medications other than insulin (especially SGLT2 inhibitors) - You exercise more than 3.5 hours per week in structured activity - You are pregnant, breastfeeding, or not using contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALKetogenic Diet

Participants will consume a very-low-carbohydrate ketogenic diet for 12 weeks.

BEHAVIORALStandard Diet

Participants will consume an American Diabetes Association-recommended standard diet for 12 weeks.


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT06503809


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