Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06503809
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Ketogenic Diet — BEHAVIORAL
    Participants will consume a very-low-carbohydrate ketogenic diet for 12 weeks.
  • Standard Diet — BEHAVIORAL
    Participants will consume an American Diabetes Association-recommended standard diet for 12 weeks.

Study Details

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.

Key Dates

Start date
Aug 12, 2024
Status verified
Mar 2026
Primary completion
Feb 28, 2030
Completion
Mar 31, 2030

Study Design

Enrollment
58 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ketogenic Diet
    The Ketogenic Diet group will consume a very-low carbohydrate diet (\<50 g/day) diet. Participants will receive isocaloric packed-out meals for 12 weeks.
  • Active Comparator: Standard Care
    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 12 weeks.

Primary Outcome Measure

Change in continuous glucose monitor (CGM) time-in-range [ Time Frame: Before and immediately after the dietary intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Tara Wilmot, RDN
[email protected]
314-399-8576
Max C Petersen, MD PhD
[email protected]
314-362-8450
Samuel Klein, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Washington University School of Medicine· St Louis, MO

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