As more adolescents with type 1 diabetes (T1D) opt to follow very low carbohydrate diets to improve glucose control, it is becoming increasingly important to study the metabolic and neurological changes that occur on these diets and how these effect patient safety. Understanding the impact of dietary changes on metabolic and neurological factors will help guide clinical advice about the overall safety and efficacy of these diets in the pediatric T1D population. This work will be the basis of future studies testing dietary interventions to improve glycemic control and ensure that these dietary interventions are safe for growing youth with T1D.
The primary objective of this randomized crossover study is to determine whether a very low carbohydrate diet improves glycemic changes (measured by continuous glucose monitors) when compared to a standard carbohydrate diet in youth with type 1 diabetes. The secondary objectives of the study are to compare metabolic changes after 2 weeks on each diet using the 2-step hyperinsulinemic euglycemic-hypoglycemic clamp and stable isotope infusions. The euglycemic portion of the clamp will allow us to determine the hepatic glucose production and adipose tissue lipolysis. Secondary objectives also include measuring the neurohormonal response to hypoglycemia after 2 weeks on each diet.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
19
Participants will engage in a diet that limits carbohydrate intake to 15% of total daily calories for 2 weeks.
Participants will engage in a diet that recommends standard carbohydrate intake with respect to total daily calories for 2 weeks.
Yale-New Haven Hospital
New Haven, Connecticut, United States
Percent Time in the Optimal Glucose Range
Time in the optimal glucose range will be operationally defined as the percent time spent in the target range of 70-180 mg/dL during the 2 weeks.
Time frame: 2 weeks
Percent Time Spent With Hypoglycemia.
Time spent with hypoglycemia will be operationally defined as the percent time spent in the hypoglycemic ranges during 2 weeks of diet. Level 2 hypoglycemia defined as \<54 mg/dL. Level 1 hypoglycemia defined as 54-69 mg/dL.
Time frame: 2 weeks
Percent Time Spent With Hyperglycemia
Time spent with hyperglycemia will be operationally defined as the percent time spent in the hyperglycemic ranges during 2 weeks of diet. Level 1 hyperglycemia defined as 181-250 mg/dL. Level 2 hyperglycemia defined as \>250 mg/dL.
Time frame: 2 weeks
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