Ketosis and Brain Function in Type 1 Diabetes
This study is looking at how a very low carbohydrate diet (ketogenic diet) affects brain function in people with type 1 diabetes (T1D). Researchers want to understand if this diet can help your brain tolerate low blood sugar (hypoglycemia) better. You might be able to join if you are 18-40 years old, have had T1D for at least a year, use an insulin pump and continuous glucose monitor (CGM), and have stable blood sugar control (HbA1c between 6.5-9%). The study will compare a very low carbohydrate diet to a standard carbohydrate diet. Success will be measured by seeing if the ketogenic diet changes the blood sugar level at which a part of your brain called the hypothalamus becomes active during low blood sugar. The current status of this study is unclear.
- Study design
- This is an interventional study that will involve 24 participants with type 1 diabetes. Participants will be randomly assigned to either a very low carbohydrate diet or a standard carbohydrate diet for 12 weeks.
- What's involved
- Participants will have all meals delivered and will eat only study foods. You will also receive supplements and have your diet adjusted for satiety. The study involves insulin infusions, neuroimaging (MRI), and assessments of blood levels, reaction time, and cognitive performance.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, glycemic threshold for hypothalamic activation, is measured between week 5 and 12 of the diet.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Effects of Ketosis on Brain Function in Patients With T1DM
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Glycemic threshold for hypothalamic activationDiet week 5-12
The blood glucose level at which hypothalamic activation is detected by continuous BOLD functional MRI during a 40 min glycemic descent from 90 to 50 mg/dL