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Tests a ketogenic diet's effects on brain function in type 1 diabetes

Compares a low carbohydrate diet with standard diet in adults with type 1 diabetes.

Key facts

Who runs it
Boston Children's Hospital
Where
Boston, United StatesSee the site
Trial code
Registry title
Effects of Ketosis on Brain Function in Patients With T1DM
Status
Recruiting
People taking part
24 people, planned
Started
3 Jan 2020
Planned end
31 Jul 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Very low carbohydrate diet
  • Standard carbohydrate diet
Record updated
18 December 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 40 with type 1 diabetes. It studies how a very low carbohydrate diet affects the brain and low blood sugar.

Age
18 to 40 years
Sex
Men and women can join.
Disease stage
Type 1 diabetes for at least 1 year, with stable blood sugar control (HbA1c 6.5-9% (48–75 mmol/mol)). Tanner stage IV or higher. BMI 18.5-35 kg/m2.
Earlier treatment
Must use an insulin pump and a continuous glucose monitor. Must have attended at least 1 diabetes care visit in the past 12 months.

Main reasons for not taking part

  • Ketoacidosis, or severe low blood sugar with seizure or coma, in the past 6 months
  • Pregnancy or breastfeeding
  • Following a weight-loss or other restrictive diet, or a food problem that does not fit the planned meals
  • History of an eating disorder or at risk for one
  • Major illness, significant psychiatric illness, or medicines other than insulin and metformin that could affect blood sugar

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • Smoking, use of recreational drugs, or excessive alcohol consumption
  • For participants who undergo MRI:; Standard MRI exclusion criteria; Irregular menses; 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)
  • 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
  • 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
  • Following a weight-loss or otherwise restrictive diet
  • Vigorous exercise >2 hours on >3 days a week
  • Pregnancy or breastfeeding
  • Anemia

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 40 years old?

Where in United States

  • Boston Childrens HospitalBoston, United StatesContact: Belinda Lennerz, MD PhDTaking people

About the trial

What the trial wants to find out

The scientific goal of this study is to examine the effects of a ketogenic diet on hypoglycemia tolerance and brain function in people with type 1 diabetes mellitus (T1D) and to clarify the mechanistic role of ketones in this process. Glycemic management of T1D is typified by alternating periods of hyper- and hypo-glycemia. Because brain metabolism under usual conditions depends on glucose, acute hypoglycemia leads to immediate complications including impaired cognitive function and a counter-regulatory hormone response. Recurrent hypoglycemia is associated with functional and structural changes in the brain and contributes to the cognitive decline observed in individuals with diabetes. The state of nutritional ketosis (as it occurs during fasting or when following a ketogenic [very low carbohydrate] diet) may protect against these acute and chronic complications. As the body relies on fat metabolism, ketone bodies build up and provide an alternative fuel for the brain. Studies during hypoglycemia have shown better cognitive function and less hypoglycemia symptoms in the setting of nutritional ketosis or with ketone administration. This physiological benefit may have special relevance for people with T1D who experience hypoglycemia frequently. To date, no mechanistic studies have examined brain effects of nutritional ketosis in T1D; nor have any trials explored the potential relevance of this for diabetes care.

The 2 groups in the trial

  • Very low carbohydrate dietTreatment being tested

    Dietary Intervention, food delivery

  • Standard dietExisting treatment, for comparison

    Dietary Intervention, food delivery

    Treatment: Standard carbohydrate diet

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Brain Function, Cognition, and Hypoglycemia Tolerance in Patients With Type 1 Diabetes Mellitus in the Setting of Nutritional Ketosis Versus Standard Carbohydrate Diet
Plain-language title
Tests a ketogenic diet's effects on brain function in type 1 diabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT04219709, who can take part
Record updated
18 December 2024