Effects of Ketosis on Brain Function in Patients With T1DM (NCT04219709)
Brain Function, Cognition, and Hypoglycemia Tolerance in Patients With Type 1 Diabetes Mellitus in the Setting of Nutritional Ketosis Versus Standard Carbohydrate Diet
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Boston Childrens Hospital — Boston, Massachusetts
Age range: 18 Years to 40 Years
🧪 Interventions in This Study
- Very low carbohydrate diet (OTHER)
- Standard carbohydrate diet (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Boston Childrens Hospital — Boston, Massachusetts
📞 Contact the Study Coordinator
Phone: (617) 355-7476
Email: belinda.lennerz@childrens.harvard.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Type1diabetes
- Physiologic Markers of Cardiometabolic Risk in People With Type 1 Diabetes — New Haven, Connecticut
- REACHOUT Mental Health Support Mobile App — Vancouver, British Columbia
- Pancreas Ultrasound Imaging in type1 Diabetes — Aurora, Colorado
- Genetics Of Autoimmunity In Type I Diabetes — Milwaukee, Wisconsin
- Glycemic Variations During the Menstrual Cycle in Women With Type 1 Diabetes — Montreal, Quebec
Explore by condition: All Type1diabetes clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.