Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes

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.

Eligibility

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.

Conditions2

Locations1 site

Browse More Trials