Effects of Ketosis on Brain Function in Patients With T1DM

Launched by BOSTON CHILDREN'S HOSPITAL · Jan 3, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how a ketogenic diet, which is very low in carbohydrates, affects brain function and the body's ability to handle low blood sugar (hypoglycemia) in people with type 1 diabetes (T1D). The research aims to understand if ketones, which are produced when fat is used for energy instead of sugar, can help protect the brain from problems caused by repeated episodes of low blood sugar. These problems can include difficulty thinking clearly and other cognitive issues, which are more common in people with diabetes who frequently experience low blood sugar.

To participate in this trial, individuals need to be between 18 and 40 years old, have been diagnosed with T1D for at least one year, and have stable blood sugar control. They should also use a continuous glucose monitor and an insulin pump. Participants can expect to follow a specific diet and will have regular check-ins to monitor their health and brain function. It's important to note that certain medical conditions and dietary restrictions may prevent someone from joining the study, so eligibility will be carefully assessed. This trial could provide valuable insights into improving diabetes care and brain health for those living with type 1 diabetes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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)
• Exclusion Criteria:
• • 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
• • History of an eating disorder or at risk for eating disorder, assessed by the Eating Disorders Diagnostic Scale (EDDS)
• • Major medical illness or use of medications other than insulin and metformin that could interfere with metabolic or glycemic variables
• • Significant psychiatric illness
• • Smoking, use of recreational drugs, or excessive alcohol consumption
• • Pregnancy or breastfeeding
• • Anemia
• * For participants who undergo MRI:
• • 1. Standard MRI exclusion criteria
• • 2. Irregular menses
• • 3. Use of psychotropic medication other than SSRIs or other mild antidepressant or anxiety medications (unless these medications are safe to be held for several days to allow for the acquisition of MRI data).