Status:
COMPLETED
Effects of Low-calorie Sweetened Beverage Restriction in Youth With Type 1 Diabetes
Lead Sponsor:
Allison Sylvetsky (Meni)
Collaborating Sponsors:
Children's National Research Institute
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
6-12 years
Phase:
NA
Brief Summary
This study will investigate whether low-calorie sweeteners (LCS) are helpful or harmful for preventing diabetes complications among children with Type 1 Diabetes (T1D).
Detailed Description
Eligible participants will be scheduled for a baseline visit. During the week prior, they will be instructed to continue usual dietary habits and complete an online photo-assisted food record, with pa...
Eligibility Criteria
Inclusion
- Child 6-12 years old
- Report consumption of ≥ 12 oz. beverages with sucralose (+/- ace-K) or aspartame+ace-K per day
- Child has had a diagnosis of T1D for at least one year
- Parent/guardian has reliable phone and internet access
- Parent/guardian and child both speak English
- Child is enrolled in the Diabetes Program at Children's National Hospital
Exclusion
- Child under 6 years of age
- Child older than 12 years of age
- Child consumes foods with low-calorie sweeteners more than 3 times per week
- Child consumes condiments with low-calorie sweeteners more than 3 times per week
- Child has poorly managed chronic disease other than T1D or is taking medications other than insulin
Key Trial Info
Start Date :
October 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04385888
Start Date
October 28 2020
End Date
December 30 2023
Last Update
August 26 2025
Active Locations (1)
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1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010