NCT07434544

Brief Summary

This project will apply a novel non-nutritive sweetener (NNS) dietary assessment tool with measurement of circulating NNS levels in a pediatric population, allowing correlation of NNS exposure to clinically meaningful cardiometabolic health outcomes.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
44mo left

Started Jun 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2026

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

February 25, 2026

Status Verified

January 1, 2026

Enrollment Period

2.6 years

First QC Date

January 27, 2026

Last Update Submit

February 20, 2026

Conditions

Non-Nutritive SweetenerType 1 Diabetestype1diabetesType 1 Diabetes Mellitus

Keywords

Non-Nutritive SweetenersType 1 DiabetesCardiometabolicLong standing

Outcome Measures

Primary Outcomes (1)

  • Change in "in vivo" endothelial function and vascular stiffness

    Brachial artery ultrasound will measure flow-mediated dilation % (FMD%) at baseline and 1 hour after drinking a non-nutritive sweetened sports drink.

    2 years (duration of study)

Secondary Outcomes (4)

  • Associations of circulating NNS levels with self-reported food frequency assessments

    2 years (duration of study)

  • Impact of chronic NNS dietary consumption on cardiovascular health

    2 years (duration of study)

  • Impact of chronic NNS dietary consumption on metabolic health

    2 years (duration of study)

  • Impact of chronic NNS dietary consumption of T1D specific glycemic control

    2 years (duration of study)

Study Arms (1)

Treatment Group

EXPERIMENTAL

Sports Drink - Participants will drink a cherry sports drink within 10 minutes.

Dietary Supplement: Cherry Sports Drink

Interventions

Cherry Sports DrinkDIETARY_SUPPLEMENT

12 oz bottle (1 1/2 cups) of Gatorade G Zero Glacier Cherry™ Sports Drink

Also known as: Gatorade Zero Glacier Cherry™
Treatment Group

Eligibility Criteria

Age15 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Aged 15-24 years
  • Clinical diagnosis of type 1 diabetes, requiring insulin therapy, of ≥ 1 to \< 10 years duration.
  • Last available HbA1c ≤ 8.5% (obtained by chart review in Children's Wisconsin Diabetes Clinic patients or verbally by individuals not receiving diabetes care at Children's Wisconsin)
  • Current use of an FDA approved automated insulin delivery (AID) system
  • Willing to consume a 12 ounce Gatorade G Zero Glacier Cherry drink in less than 10 minutes
  • Willing and able to give informed consent or have parent or legal guardian provide informed consent if the subject is \< 18 years of age

You may not qualify if:

  • Any disease other than type 1 diabetes that affects glucose, sex steroid, or fat metabolism such as polycystic ovary syndrome or hypercortisolism
  • Any medication use that may affect glucose, sex steroid, or fat metabolism such as metformin or glucocorticoids
  • Half or full sibling already participating in this study
  • Known cardiovascular disease such as hypertension or atherosclerosis, and/or use of an anti-hypertensive medication
  • Known hyperlipidemia, defined as LDL ≥ 160 mg/dL, and/or use of lipid-lowering medication, such as statin therapy
  • Known renal disease or microalbuminuria, and/or use of angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blockers (ARBs) for microalbuminuria
  • Known diabetic retinopathy or neuropathy
  • Raynaud's phenomenon or other vascular disease
  • Obesity and/or body habitus that precludes completion of the flow-mediated brachial ultrasound study (generally, BMI \> 40 kg/m2 in adults) - this is at study team's discretion.
  • Pregnancy or lactation
  • Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Susanne M Cabrera, MD

CONTACT

414-955-4903T1dinfo@mcw.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Single-arm pre-post study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Medicine; Endocrinology

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 25, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

February 25, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)