Effects of Low-calorie Sweetened Beverage Restriction in Youth With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Effects of Low-calorie Sweetened Beverage Restriction in Youth With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04385888
• Other study ID #: Pro00012436
• Status: Completed
• Phase: N/A
• Start date: October 28, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2024
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 parental assistance. At the baseline visit, height and weight will be measured, a spot urine sample will be collected, and a blood draw will be performed. Participants will have their CGM data for the past two weeks downloaded. In a subset of participants, an abdominal MRI will also be performed.

Subjects will then be randomized to either: 1) low-calorie sweetener (LCS) restriction or 2) continuation of usual LCS intake (control). All participants (both groups) and their parent will undergo a brief, 20-minute orientation where the PI and study dietitian will provide an introduction to the study, instructions on completing food records, education on CGM. Those in the intervention group will be given sample replacement beverages and a brochure on avoiding LCS to take home which will include a list of specific foods and beverages containing LCS to avoid during the study. Participants in the control group will be counseled on healthy eating as those in the intervention group (in accordance with standard dietary guidance for T1D management), with the exception of information and resources for avoiding LCS.

In both groups, text messages will be sent to parents 3X/week with reminders that their child should avoid LCS or continue usual intake, per randomization. Adherence will be monitored through collection of spot-urine samples for measurement of sucralose and ace-K concentrations. daily text message beverage logs completed by the parent, and photo-assisted food records with parent assistance in Weeks 0, 1, 6, and 12. During Week 6, participants and their parent will attend a mid-intervention telemedicine booster visit, during which the PI and/or study RA will reinforce the intervention and remind participants to mail back a spot urine sample using materials provided by the study team at baseline. Participants will be reminded of the study instructions, including the importance of inserting the DEXCOM G6 sensor (provided by study team) at the beginning of Week 11.

At the end of Week 12, participants and their parent will return for follow-up. Participants will have their CGM data downloaded using DEXCOM Clarity™ software. Height and weight will be measured and a second blood draw performed. Those who had an MRI at the baseline visit (n=30) will undergo a second abdominal MRI. Those randomized to the intervention will be purposefully sampled and asked to complete a ~20 minute qualitative interview and ~5 minute satisfaction survey, together with their parent, about their study experience and the challenges of LCSB restriction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

1. Child 6-12 years old

2. Report consumption of = 12 oz. beverages with sucralose (+/- ace-K) or aspartame+ace-K per day

3. Child has had a diagnosis of T1D for at least one year

4. Parent/guardian has reliable phone and internet access

5. Parent/guardian and child both speak English

6. Child is enrolled in the Diabetes Program at Children's National Hospital

Exclusion Criteria:

1. Child under 6 years of age

2. Child older than 12 years of age

3. Child consumes foods with low-calorie sweeteners more than 3 times per week

4. Child consumes condiments with low-calorie sweeteners more than 3 times per week

5. Child has poorly managed chronic disease other than T1D or is taking medications other than insulin

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Low-calorie sweetener restriction
Participants will avoid low-calorie sweetened beverages and other sources of low-calorie sweeteners for 12 weeks and will instead consume unsweetened alternatives, such as still or sparkling water

Locations

Country	Name	City	State
United States	Children's National Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Allison Sylvetsky (Meni)	Children's National Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Variability	Change in Time in Range (TIR)	Baseline vs Weeks 11-12
Secondary	Visceral adiposity	Visceral fat area will be assessed using abdominal MRI	Baseline vs. Week 12
Secondary	Inflammatory cytokines (e.g. IL-6)	We will collect a blood sample to measure inflammatory cytokines.	Baseline vs Week 12