Brain Function, Cognition, and Hypoglycemia Tolerance in Patients With Type 1 Diabetes Mellitus in the Setting of Nutritional Ketosis Versus Standard Carbohydrate Diet

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• Males and females with T1D for at least 1 year

• Age 18 to 40 years

• Tanner stage ≥ IV

• BMI 18.5-35 kg/m2

• Stable glycemic control (HbA1c 6.5-9%)

• Use of a continuous glucose monitor (CGM)

• Use of an insulin pump

• Attendance of at least 1 diabetes care visit over the past 12 months (including virtual)

Locations
United States
Massachusetts
Boston Childrens Hospital
RECRUITING
Boston
Contact Information
Primary
Belinda Lennerz, MD PhD
belinda.lennerz@childrens.harvard.edu
+1 617 355 7476
Time Frame
Start Date: 2020-01-03
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 24
Treatments
Experimental: Very low carbohydrate diet
Dietary Intervention, food delivery
Active_comparator: Standard diet
Dietary Intervention, food delivery
Sponsors
Collaborators: Beth Israel Deaconess Medical Center
Leads: Boston Children's Hospital

This content was sourced from clinicaltrials.gov