Effects of a ketogenic diet on brain function in people with type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Continuous Glucose Monitor Accuracy and Safety in Adults with Type 1 Diabetes

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• Cardiometabolic effects of non-nutritive sweeteners in Type 1 diabetes

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  Recruiting Medical College of Wisconsin · Milwaukee, Wisconsin · NCT07434544

• Wearable continuous glucose and ketone monitor for adults with type 1 diabetes

  This trial will test if a new wearable device can continuously and accurately measure glucose and ketone levels in adults with type 1 diabetes.

  Recruiting at 2 sites Henan University of Science and Technology · Shijiazhuang, Hebei and 1 other locations · NCT07139808

• Tirzepatide for obesity in people with type 1 diabetes

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• New real-time continuous glucose monitor accuracy and safety in adults with type 1 diabetes

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  Recruiting Henan University of Science and Technology · Luoyang, Henan · NCT07092761

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.