Very Low Carbohydrate Diets and Glucagon Response in T1DM

Launched by BOSTON CHILDREN'S HOSPITAL · Dec 12, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how a very low-carbohydrate diet (VLC) affects the body’s response to glucagon in people with type 1 diabetes (T1D). Glucagon is a medication used to raise blood sugar levels during severe low blood sugar events. The researchers want to see if following a VLC diet for 12 weeks will still allow the body to respond adequately to glucagon, ensuring safety during times of low blood sugar. They have previously seen good results with VLC diets, but there are concerns about how it might affect growth and the risk of very low blood sugar.

To be eligible for this study, participants need to be between 18 and 40 years old, have had T1D for at least one year, and maintain stable blood sugar levels. This means they should have an HbA1c (a measure of average blood sugar) between 6.5% and 9%. Participants will need to use both an insulin pump and a continuous glucose monitor. During the trial, they can expect to be assigned to either the VLC diet or a standard diet and will undergo tests to monitor how their bodies respond to glucagon after a period of fasting. This study aims to provide more information on the safety and effectiveness of VLC diets for people with T1D.

Gender

ALL

Eligibility criteria

• 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).