Testing a ketogenic diet for better blood sugar control in type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of a very-low-carbohydrate ketogenic diet in adults with type 1 diabetes. The study aims to determine if this diet can improve blood sugar control, reduce insulin requirements, and enhance metabolic function over a 12-week period. Participants will be randomly assigned to either the ketogenic diet or a standard diet recommended by the American Diabetes Association. The trial will also assess the socio-behavioral impact and acceptability of the ketogenic diet compared to the control diet.

Why it matters

Who can join: the full rules

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.

Where it's running

• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Samuel Klein, MD — Washington University School of Medicine
• Study coordinator: Tara Wilmot, RDN
• Email: tara.wilmot@wustl.edu
• Phone: 314-399-8576

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.