Metabolic Changes Induced by a Very Low Carbohydrate Diet in Youth With Type 1 Diabetes

Not Applicable

Completed

Interventions: Other: low carbohydrate diet
Other: standard carbohydrate diet

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Diagnosis of type 1 diabetes for at least 1 year
Hemoglobin A1c level < 10% within the past 2 months
Provision of signed and dated informed consent form by the adult (if person is at least 18 years old) or parent and assent form if the participant is <18 years old.
Stated willingness to comply with all study procedures and availability for the duration of the study
Male, female, transgender, nonbinary are all eligible
Diagnosis of type 1 diabetes for at least 1 year
Insulin pump use for at least 2 months.
Ability to perform daily blood ketone checks, wear a continuous glucose monitor, willing to wear an activity monitor, willing to adhere to the study diets and keep a diet journal.
For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of the dietary intervention.
For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner

Arm && Interventions

Group	Intervention	Description
low carbohydrate diet	low carbohydrate diet	In this crossover study, participants will be randomized to either a low or standard carbohydrate for 2 weeks. Participants in the low carbohydrate group will limit carbohydrate intake to 15% of total daily calories.
standard carbohydrate diet	standard carbohydrate diet	In this crossover study, participants will be randomized to either a low or standard carbohydrate for 2 weeks. Participants in the standard carbohydrate group will follow an ad libitum diet with standard carbohydrate intake.

Primary Outcome Measures

Name	Time	Method
Time in the optimal glucose range	2 weeks	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 2 weeks the diet.

Secondary Outcome Measures

Name	Time	Method
Time spent with hyperglycemia	2 weeks	Time spent with hyperglycemia will be operationally defined as the percent time spent in the hyperglycemic (\>180 mg/dL, \>250 mg/dL) ranges during 2 weeks of diet.
Time spent with hypoglycemia.	2 weeks	Time spent with hypoglycemia will be operationally defined as the percent time spent in the hypoglycemic (\<54 mg/dL, \<70 mg/dL) ranges during 2 weeks of diet.

Locations (1): Yale-New Haven Hospital
🇺🇸
New Haven, Connecticut, United States