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.

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NCT04219709

Effects of Ketosis on Brain Function in Patients With T1DM

Recruiting
NAAges 18–40InterventionalSupportive care
Boston Children's Hospital
~24 participants
Updated 2024-12-18 on ClinicalTrials.gov
What's tested:Very low carbohydrate dietStandard carbohydrate diet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Glycemic threshold for hypothalamic activation
Measured over Diet week 5-12
Type1diabetes
1 sites across 1 states
Massachusetts1

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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:
  • 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