RECRUITING

Effects of Ketosis on Brain Function in Patients With T1DM

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2020-01-03
Study Completion:2024-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04219709

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males and females with T1D for at least 1 year
  2. * Age 18 to 40 years
  3. * Tanner stage ≥ IV
  4. * BMI 18.5-35 kg/m2
  5. * Stable glycemic control (HbA1c 6.5-9%)
  6. * Use of a continuous glucose monitor (CGM)
  7. * Use of an insulin pump
  8. * Attendance of at least 1 diabetes care visit over the past 12 months (including virtual)
  1. * Ketoacidosis or severe hypoglycemia with seizure or coma in the past 6 months
  2. * Dietary restrictions or intolerances that are incompatible with the planned food deliveries, e.g. celiac disease, gastroparesis, certain food allergies
  3. * Following a weight-loss or otherwise restrictive diet
  4. * Vigorous exercise \>2 hours on \>3 days a week
  5. * History of an eating disorder or at risk for eating disorder, assessed by the Eating Disorders Diagnostic Scale (EDDS)
  6. * Major medical illness or use of medications other than insulin and metformin that could interfere with metabolic or glycemic variables
  7. * Significant psychiatric illness
  8. * Smoking, use of recreational drugs, or excessive alcohol consumption
  9. * Pregnancy or breastfeeding
  10. * Anemia
  11. * For participants who undergo MRI:
  12. 1. Standard MRI exclusion criteria
  13. 2. Irregular menses
  14. 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).

Contacts and Locations

Study Contact

Svetlana Azova, MD
CONTACT
617-919-6675
svetlana.azova@childrens.harvard.edu
Belinda Lennerz, MD, PhD
CONTACT
857-218-3896
belinda.lennerz@childrens.harvard.edu

Principal Investigator

Belinda Lennerz, MD, PhD
PRINCIPAL_INVESTIGATOR
Boston Children's Hospital

Study Locations (Sites)

Boston Children's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

  • Belinda Lennerz, MD, PhD, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-03
Study Completion Date2024-07-31

Study Record Updates

Study Start Date2020-01-03
Study Completion Date2024-07-31

Terms related to this study

Keywords Provided by Researchers

  • nutrition
  • very low carbohydrate diet
  • ketogenic diet
  • nutritional ketosis
  • cognitive function
  • brain
  • metabolism
  • ketones
  • ketosis

Additional Relevant MeSH Terms

  • Type1diabetes