RecruitingNot ApplicableNCT04219709

Effects of Ketosis on Brain Function in Patients With T1DM

Brain Function, Cognition, and Hypoglycemia Tolerance in Patients With Type 1 Diabetes Mellitus in the Setting of Nutritional Ketosis Versus Standard Carbohydrate Diet

Sponsor

Boston Children's Hospital

Enrollment

24 participants

Start Date

Jan 3, 2020

Study Type

INTERVENTIONAL

Conditions

Type1diabetes

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether a ketogenic (very low carbohydrate) diet that induces a state of ketosis affects brain function and mental performance in adults with Type 1 diabetes, compared to a standard diet. **You may be eligible if...** - You have had Type 1 diabetes for at least 1 year - You are 18 to 40 years old - You use both a continuous glucose monitor (CGM) and an insulin pump - Your blood sugar is reasonably stable (HbA1c between 6.5% and 9%) - You have had at least one diabetes care visit in the past 12 months **You may NOT be eligible if...** - You have had a severe low blood sugar episode or diabetic ketoacidosis in the past 6 months - You have dietary restrictions (celiac disease, gastroparesis, severe food allergies) incompatible with the study meals - You are on a restrictive or weight-loss diet - You exercise intensely more than 2 hours on more than 3 days per week - You have a history of an eating disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERVery low carbohydrate diet

All meals will be delivered and participants will consume study foods exclusively. Participants will receive a fiber supplement with each meal as needed to promote digestive health, and a daily multi-vitamin, magnesium and omega-3 supplement to ascertain micronutrient sufficiency. Participants will be weighed at each study visit and the diet plan will be adjusted for satiety and weight-maintenance. The diet composition will be as follows: 5% carbohydrate, 75% fat, 20% protein.

OTHERStandard carbohydrate diet

All meals will be delivered and participants will consume study foods exclusively. Participants will receive a daily multi-vitamin and omega-3 supplement to ascertain micronutrient sufficiency. Participants will be weighed at each study visit and the diet plan will be adjusted for satiety and weight-maintenance. The diet composition will be as follows: 50% carbohydrate, 30% fat, 20% protein.