Effects of a ketogenic diet on brain function in people with type 1 diabetes
Brain Function, Cognition, and Hypoglycemia Tolerance in Patients With Type 1 Diabetes Mellitus in the Setting of Nutritional Ketosis Versus Standard Carbohydrate Diet
This study is testing if a ketogenic diet can help young adults with type 1 diabetes better handle low blood sugar and improve their brain function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04219709 on ClinicalTrials.gov |
What this trial studies
This study examines how a ketogenic diet influences hypoglycemia tolerance and cognitive function in individuals with type 1 diabetes mellitus (T1D). It involves a randomized controlled trial with 32 young adults who will follow either a ketogenic or a standard carbohydrate diet for 12 weeks. Researchers will utilize insulin infusions and neuroimaging techniques to assess brain activation and connectivity during episodes of hypoglycemia. The goal is to understand the protective role of ketones on brain metabolism and cognitive performance during low blood sugar events.
Who should consider this trial
Good fit: Ideal candidates are young adults aged 18 to 40 with type 1 diabetes for at least one year and stable glycemic control.
Not a fit: Patients with recent severe hypoglycemia, dietary restrictions incompatible with the study, or significant psychiatric illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of cognitive function and hypoglycemia tolerance in patients with type 1 diabetes.
How similar studies have performed: Other studies have shown promising results with ketogenic diets in metabolic conditions, but this specific approach in T1D is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Boston, Massachusetts
- Boston Childrens Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Belinda Lennerz, MD PhD
- Email: belinda.lennerz@childrens.harvard.edu
- Phone: +1 617 355 7476
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.