Safety and Feasibility of a Low Carbohydrate Diet in Children With Type 1 Diabetes
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low carbohydrate diet
Sponsored by
About this trial
This is an interventional other trial for Type 1 Diabetes
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
Sites / Locations
- St Louis Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Low carb diet intervention group
Control
Arm Description
Low carbohydrate diet defined as 25-35% of total energy intake
Standard diet defined as 45-65% total energy intake
Outcomes
Primary Outcome Measures
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).
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.
Dyslipidemia
Investigators will evaluate the changes in LDL levels among the study groups.
Secondary Outcome Measures
Glycemic control
Investigators will evaluate the changes in glycemic control among the groups using HbA1c at baseline, 3 and 6 months.
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).
Full Information
NCT ID
NCT04228822
First Posted
December 11, 2019
Last Updated
March 7, 2022
Sponsor
Washington University School of Medicine
Collaborators
ICTS BJH, Center for Diabetes Translation Research
1. Study Identification
Unique Protocol Identification Number
NCT04228822
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 10, 2020 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
ICTS BJH, Center for Diabetes Translation Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
20 participants will be randomized to the intervention group (low carbohydrate diet) and 20 participants will be randomized to the control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low carb diet intervention group
Arm Type
Experimental
Arm Description
Low carbohydrate diet defined as 25-35% of total energy intake
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard diet defined as 45-65% total energy intake
Intervention Type
Other
Intervention Name(s)
Low carbohydrate diet
Intervention Description
25-35% of carbohydrates from total energy intake
Primary Outcome Measure Information:
Title
Number of hypoglycemic events
Description
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).
Time Frame
6 month study period
Title
Episodes of diabetes related visits to the hospital, DKA
Description
Investigators will obtain data prospectively from medical records and will estimate the frequency of DKA, diabetes related hospitalizations / emergency department visits.
Time Frame
6 month study period
Title
Dyslipidemia
Description
Investigators will evaluate the changes in LDL levels among the study groups.
Time Frame
6 month study period
Secondary Outcome Measure Information:
Title
Glycemic control
Description
Investigators will evaluate the changes in glycemic control among the groups using HbA1c at baseline, 3 and 6 months.
Time Frame
6 month duration of the study
Title
Glucose variability
Description
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).
Time Frame
6 month study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
St Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety and Feasibility of a Low Carbohydrate Diet in Children With Type 1 Diabetes
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