Safety and Feasibility of a Low Carbohydrate Diet in Children With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Safety and Feasibility of a Low Carbohydrate Diet in Children With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04228822
• Other study ID #: 201911121
• Status: Completed
• Phase: N/A
• Start date: November 10, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• Low carbohydrate diet
25-35% of carbohydrates from total energy intake

Locations

Country	Name	City	State
United States	St Louis Children's Hospital	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	Center for Diabetes Translation Research, ICTS BJH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of hypoglycemic events	Using a continuous glucose monitor (CGM) and home glucose meter, investigators will calculate the number of hypoglycemic events (glucose values <70 mg/dL but = 54 mg/dL and those <54 mg/dL), number of severe hypoglycemia and time spent in hypoglycemia (values <70 mg/dL but = 54 mg/dL and <54 mg/dL).	6 month study period
Primary	Episodes of diabetes related visits to the hospital, DKA	Investigators will obtain data prospectively from medical records and will estimate the frequency of DKA, diabetes related hospitalizations / emergency department visits.	6 month study period
Primary	Dyslipidemia	Investigators will evaluate the changes in LDL levels among the study groups.	6 month study period
Secondary	Glycemic control	Investigators will evaluate the changes in glycemic control among the groups using HbA1c at baseline, 3 and 6 months.	6 month duration of the study
Secondary	Glucose variability	Using CGM data investigators will evaluate glucose variability using standard deviation (SD) of all glucose values. Secondary endpoints will include time of the day spent in range (values between 70-140 mg/dl and between 70 and 180mg/dl), in hypoglycemia (values <70 mgl/dl but = 54 mg/dl and <54 mg/dl) and in hyperglycemia (values >180mg/dl and >250 mg/dl).	6 month study period