Clinical trial NCT04955691: Metabolic Changes Induced by a Very Low Carbohydrate Diet in Youth With Type 1 Diabetes
Official title: Metabolic and Neurological Changes Induced by a Very Low Carbohydrate Diet in Youth With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1diabetes, Low Carbohydrate Diet
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-07-09
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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
* All sexes are 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

Exclusion Criteria:

* Current use of glucose-lowering agents other than insulin
* Unstable psychiatric disorders, including eating disorders
* Weight loss medications within the last 6 months
* Pregnancy or lactation, or planning pregnancy within the next 6 months
* BMI \< 19 kg/m2 for individuals 18 years of age or older
* BMI \< 5%ile for individuals under 18 years
* Weight less than 49 kg or 108 pounds
* Other medical conditions that may interfere with glucose metabolism and insulin sensitivity

Primary outcomes:
measure: Time in the optimal glucose range
timeFrame: 2 weeks
Secondary outcomes:
measure: Time spent with hypoglycemia.
timeFrame: 2 weeks
measure: Time spent with hyperglycemia
timeFrame: 2 weeks
Other outcomes:
measure: Human Factors
timeFrame: 8 weeeks
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
Study officials:
References: