Clinical trial NCT04228822: Safety and Feasibility of a Low Carbohydrate Diet in Children With Type 1 Diabetes
Official title: Safety and Feasibility of a Low Carbohydrate Diet in Children With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: ICTS BJH
name: Center for Diabetes Translation Research
First posted: 2020-01-14
Enrollment: 8
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 20 participants will be randomized to the intervention group (low carbohydrate diet) and 20 participants will be randomized to the control group
Primary purpose: OTHER

Brief summary: Good glycemic control in individuals with Type 1 diabetes (T1D), has been proven to reduce the risk of diabetes-related complications. Despite technological advances such as the use of insulin delivery devices and continuous glucose monitoring, the average glycemic control in T1D is poor. Though dietary management plays a major role in the overall management of T1D, and it is often classified as the most challenging aspect of treatment, the 2019 Standards of Medical Care in Diabetes for children and adolescents do not clearly address dietary management. As carbohydrate is the macronutrient with the greatest impact on blood glucose, it is reasonable to suggest that carbohydrate reduction will minimize postprandial glucose excursions and improve diabetes control. For this reason, low carbohydrate diets (LCD) have gained popularity, and observational studies report positive glycemic outcomes. However, to date, scientific evidence from randomized trials on the impact of LCD in children with T1D is lacking. Thus, the over-arching goal of this pilot study is to evaluate the feasibility and safety of a low carbohydrate diet in children with T1D, and as an exploratory aim, we will evaluate the efficacy of LCD on glycemic control.

Detailed description: The investigators aim to study 40 subjects ages 5-11 with T1D to evaluate the feasibility of LCD. Participants will be asked to attend a total of 5 visits (4 in person and 1 phone visit) during the 6 month-duration of the study. Participants will be randomized to an intervention group with a LCD (50% of carbohydrate recommended daily allowance) vs. the standard diet.

During the screening visit, participants will be assessed by a dietitian to categorize their existing dietary regimen before randomization to either the LCD or the standard diet. In addition, participant's insulin regimen (either pump settings or multiple dose insulin injection therapy) will be reviewed for insulin dose adjustments as needed over a 2 week-period.

Eligibility criteria: Inclusion Criteria:

* Patients 5-11 years of age, with history of Type 1 diabetes for longer than 2 years,
* No carbohydrate restrictions at the time of recruitment.
* No medications that could affect appetite
* Regular attendance at the clinic (3-4 times per year),
* Glycated hemoglobin (HbA1c) \<10%.

Exclusion Criteria:

* Impaired renal or liver function,
* Chronic seizures or global developmental delay,
* Diagnosed with ADHD and/or on ADHD medications
* Use of drugs other than insulin affecting glucose metabolism
* Severe eczema
* Celiac disease

Primary outcomes:
measure: Number of hypoglycemic events
timeFrame: 6 month study period
measure: Episodes of diabetes related visits to the hospital, DKA
timeFrame: 6 month study period
measure: Dyslipidemia
timeFrame: 6 month study period
Secondary outcomes:
measure: Glycemic control
timeFrame: 6 month duration of the study
measure: Glucose variability
timeFrame: 6 month study period
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: St Louis Children's Hospital
state: Missouri
Study officials:
References: