Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes

Exclusion Criteria20

• 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.