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Study identifier: NCT04219709 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Effects of Ketosis on Brain Function in Patients With T1DM

Condition: Type1diabetes  ·  Sponsor: Boston Children's Hospital

PhaseNA
Planned participants24
Who can joinAll sexes, 18 Years to 40 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Belinda Lennerz, MD PhD  ·  +1 617 355 7476  ·  belinda.lennerz@childrens.harvard.edu

Always discuss trial participation with your own doctor first.

Locations (1)

Boston Childrens HospitalBoston, Massachusetts, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT04219709