Effects of Ketosis on Brain Function in Patients With T1DM

ConditionType1diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorBoston Children's Hospital

About this trial

The scientific goal of this study is to examine the effects of a ketogenic diet on hypoglycemia tolerance and brain function in people with type 1 diabetes mellitus (T1D) and to clarify the mechanistic role of ketones in this process. Glycemic management of T1D is typified by alternating periods of hyper- and hypo-glycemia. Because brain metabolism under usual conditions depends on glucose, acute hypoglycemia leads to immediate complications including impaired cognitive function and a counter-regulatory hormone response. Recurrent hypoglycemia is associated with functional and structural changes in the brain and contributes to the cognitive decline observed in individuals with diabetes. The state of nutritional ketosis (as it occurs during fasting or when following a ketogenic \[very low carbohydrate\] diet) may protect against these acute and chronic complications. As the body relies on fat metabolism, ketone bodies build up and provide an alternative fuel for the brain. Studies during hypoglycemia have shown better cognitive function and less hypoglycemia symptoms in the setting of nutritional ketosis or with ketone administration. This physiological benefit may have special relevance for people with T1D who experience hypoglycemia frequently. To date, no mechanistic studies have examined brain effects of nutritional ketosis in T1D; nor have any trials explored the potential relevance of this for diabetes care.

Eligibility criteria

Qualifiers

Males and females with T1D for at least 1 year

Age 18 to 40 years

Tanner stage ≥ IV

BMI 18.5-35 kg/m2

Disqualifiers

Ketoacidosis or severe hypoglycemia with seizure or coma in the past 6 months

Dietary restrictions or intolerances that are incompatible with the planned food deliveries, e.g. celiac disease, gastroparesis, certain food allergies

Following a weight-loss or otherwise restrictive diet

Vigorous exercise >2 hours on >3 days a week

Trial design

Treatments tested in this trial

  • Very low carbohydrate diet
  • Standard carbohydrate diet

Treatment groups

24 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Boston Children's Hospital

Lead sponsor

Beth Israel Deaconess Medical Center

Collaborator