Recruiting

Ketogenic Diet

Sponsor:

Washington University School of Medicine

Code:

NCT06503809

Conditions

Diabetes Mellitus, Type 1

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Ketogenic Diet

Standard Diet

Study Details

Brief 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

Study ID

NCT06503809

Start date

Aug 12, 2024

Status verified date

Mar, 2026

Completion date

Mar 31, 2030

Anticipated

Primary completion date

Feb 28, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥18 and ≤65 years
  • T1D diagnosed >1 year prior to screening
  • HbA1c 7.0%-9.0%
  • Stable insulin delivery method for the past 30 days
  • Ability to read all device instructions and insulin pump settings
  • eGFR ≥60 mL/min/1.73 m2
  • Use of an insulin pump or insulin delivery by multiple daily injections
  • Use of personal CGM for at least 12 weeks and willing to change to Dexcom CGM for the duration of the study, if using a different sensor, to reduce variability in glucose values associated with different CGM products
  • Use of cellular phone with data capability for wireless connectivity to the CGM system.

Exclusion Criteria:

  • Body mass index <20.0 or >34.9 kg/m2
  • Severe gastroparesis or history of bariatric surgery
  • Diabetes-related hospitalization (including for diabetic ketoacidosis or severe hypoglycemia) within 12 months of screening
  • Poorly controlled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg)
  • Taking diabetes medications, other than insulin (particularly SGLT2 inhibitors, which are associated with an increased risk of euglycemic DKA)
  • Structured exercise >210 minutes per week
  • Pregnant, lactating, not using effective birth control if premenopausal, or planning to become pregnant within the 6-month study period
  • Unstable weight (>4% change in the last 2 months)
  • Significant organ system dysfunction (e.g., severe pulmonary, renal, hepatic, or cardiovascular disease)
  • Anemia (Hgb <10 g/dL)
  • Major psychiatric illness
  • Active tobacco use (>8 cigarettes/day) or illegal drug use
  • Regular alcohol consumption (>10 standard drinks per week)
  • Use of medications known to affect the study outcome measures or increase the risk of study procedures that cannot be temporarily discontinued for this study
  • Familial hypercholesterolemia
  • Active eating disorder
  • Dietary restrictions incompatible with a very-low-carbohydrate KD, vegan diet, vegetarian diet, severe lactose intolerance, severe aversion/sensitivity to eggs, fish, nuts, wheat, or soy, and any anaphylactic food allergy
  • Already consuming a low-carbohydrate (<130 g/day) diet
  • Persons who are not able to grant voluntary informed consent
  • Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers an inappropriate candidate for the study.

Study Design

Enrollment

58 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Ketogenic Diet

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

Standard Diet

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Tara Wilmot, RDN

314-399-8576tara.wilmot@wustl.edu

Max C Petersen, MD PhD

314-362-8450max.p@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Tara Wilmot, RDN

314-399-8576tara.wilmot@wustl.edu

Max C Petersen, MD PhD

314-362-8450max.p@wustl.edu

Principal Investigator:

Samuel Klein, MD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Keywords

  • Type 1 diabetes
  • Ketogenic diet
  • Insulin sensitivity
  • Continuous glucose monitoring
  • Hypoglycemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-03-19.