Low-calorie sweetener restriction for Type 1 Diabetes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Children's National Hospital, Washington, United StatesType 1 DiabetesLow-calorie sweetener restriction - Behavioral
Eligibility
6 - 12
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study whether low-calorie sweeteners help or harm in preventing diabetes complications for kids with Type 1 Diabetes.

Eligible Conditions
  • Type 1 Diabetes

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Baseline vs Weeks 11-12

Baseline vs Week 12
Inflammatory cytokines (e.g. IL-6)
Baseline vs Weeks 11-12
Glycemic Variability
Baseline vs. Week 12
Visceral adiposity

Trial Safety

Trial Design

2 Treatment Groups

Usual consumption/control
1 of 2
Low-calorie sweetener restriction
1 of 2

Active Control

Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: Low-calorie sweetener restriction · No Placebo Group · N/A

Low-calorie sweetener restriction
Behavioral
Experimental Group · 1 Intervention: Low-calorie sweetener restriction · Intervention Types: Behavioral
Usual consumption/controlNoIntervention Group · 1 Intervention: Usual consumption/control · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline vs weeks 11-12

Who is running the clinical trial?

Children's National Research InstituteOTHER
194 Previous Clinical Trials
206,427 Total Patients Enrolled
George Washington UniversityLead Sponsor
215 Previous Clinical Trials
121,410 Total Patients Enrolled

Eligibility Criteria

Age 6 - 12 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The study is only open to children between the ages of 6 and 12.
You regularly consume more than three cans of diet soda per day that contain sweeteners like sucralose or aspartame.

Frequently Asked Questions

What is the uppermost limit of participants enrolled in this clinical experiment?

"Affirmative, the information hosted on clinicaltrials.gov confirms that this trial is actively recruiting patients. The study was initially published on October 28th 2020 and was last revised on October 14th 2022; they are looking to enlist 60 individuals at a single facility." - Anonymous Online Contributor

Unverified Answer

Are there any opportunities for volunteers to join this trial?

"Evidenced by the clinicaltrials.gov website, this medical study is actively searching for participants. This trial was uploaded on October 28th 2020 and has been revised as of October 14th 2022." - Anonymous Online Contributor

Unverified Answer

Is it possible for me to join this research project?

"This clinical trial is looking to enrol 60 juvenile patients (aged 6-12) with [type 1 diabetes](https://www.withpower.com/clinical-trials/type-1-diabetes) and autoimmune conditions. Eligibility demands that the child drinks at least 12 oz of beverages with either sucralose +/–ace-K or aspartame plus ace-K daily, has had a diagnosis for over one year, speaks English fluently and resides in an area where phone and web access are reliable. Additionally, they must be enrolled in Children's National Hospital Diabetes Program." - Anonymous Online Contributor

Unverified Answer

Is this research initiative seeking out participants that exceed 30 years in age?

"The parameters for this trial necessitate that prospective participants are between 6 and 12 years of age. According to current records, there are 219 trials suited for minors and 925 studies catered towards geriatrics." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.