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Low-Calorie Sweetener Restriction for Type 1 Diabetes

N/A

Waitlist Available

Research Sponsored by George Washington University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline vs weeks 11-12

Awards & highlights

Study Summary

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

Who is the study for?

This trial is for children aged 6-12 with Type 1 Diabetes, enrolled at Children's National Hospital, who drink beverages with certain low-calorie sweeteners daily. They must have had T1D for over a year and both child and guardian should speak English and have reliable phone/internet.Check my eligibility

What is being tested?

The study examines if restricting low-calorie sweeteners can prevent diabetes complications in kids with Type 1 Diabetes. It focuses on the effects of not consuming drinks containing sucralose or aspartame combined with ace-K.See study design

What are the potential side effects?

Since this trial involves dietary restrictions rather than medication, direct side effects are minimal. However, changes in diet could potentially affect blood sugar levels or cause cravings.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline vs weeks 11-12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline vs weeks 11-12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline vs weeks 11-12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Glycemic Variability

Secondary outcome measures

Inflammatory cytokines (e.g. IL-6)

Visceral adiposity

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Low-calorie sweetener restrictionExperimental Treatment1 Intervention

Participants will be instructed to avoid low-calorie sweetened beverages and other sources of low-calorie sweeteners, and to instead consume unsweetened alternatives, such as plain or sparkling water for 12 weeks.

Group II: Usual consumption/controlActive Control1 Intervention

Participants will continue low-calorie sweetener consumption, as usual.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Children's National Research InstituteOTHER

210 Previous Clinical Trials

207,726 Total Patients Enrolled

George Washington UniversityLead Sponsor

243 Previous Clinical Trials

453,743 Total Patients Enrolled

Media Library

Low-calorie sweetener restriction Clinical Trial Eligibility Overview. Trial Name: NCT04385888 — N/A

Type 1 Diabetes Research Study Groups: Low-calorie sweetener restriction, Usual consumption/control

Type 1 Diabetes Clinical Trial 2023: Low-calorie sweetener restriction Highlights & Side Effects. Trial Name: NCT04385888 — N/A

Low-calorie sweetener restriction 2023 Treatment Timeline for Medical Study. Trial Name: NCT04385888 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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 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."

Answered by AI

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."

Answered by AI

Recent research and studies

Contemporary Clinical TrialsJournal

Rationale and Design of DRINK-T1D: A Randomized Clinical Trial of Effects of Low-calorie Sweetener Restriction in Children with Type 1 Diabetes

Sylvetsky, Allison C., Hailey R. Moore, Jasmine H. Kaidbey, Sabrina E. Halberg, Fran R. Cogen, Loretta DiPietro, Angelo Elmi, Michael I. Goran, and Randi Streisand. 2021. “Rationale and Design of DRINK-T1D: A Randomized Clinical Trial of Effects of Low-calorie Sweetener Restriction in Children with Type 1 Diabetes”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2021.106431.

clinicaltrials.govStudy

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

Allison Sylvetsky (Meni) 2020. "Effects of Low-calorie Sweetened Beverage Restriction in Youth With Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04385888.