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Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes

NCT06503809 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-03-19

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

BEHAVIORAL

Ketogenic Diet

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

BEHAVIORAL

Standard Diet

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

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Samuel Klein, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-12
Primary Completion
2030-02-28
Completion
2030-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06503809 on ClinicalTrials.gov