Testing a ketogenic diet for better blood sugar control in type 1 diabetes
Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes
This study is testing if a very-low-carbohydrate ketogenic diet can help adults with type 1 diabetes manage their blood sugar better and reduce their need for insulin.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT06503809 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with type 1 diabetes diagnosed for over a year and an HbA1c level between 7.0% and 9.0%.
Not a fit: Patients with a body mass index outside the range of 20.0 to 34.9 kg/m2 or those with severe diabetes-related complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved blood sugar management and reduced complications for patients with type 1 diabetes.
How similar studies have performed: While several observational studies have suggested benefits of a ketogenic diet in type 1 diabetes, this is the first randomized controlled trial to rigorously evaluate its efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
St Louis, Missouri
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.