NCT07434544 Cardiometabolic Effects of Non-Nutritive Sweeteners (NNS) in Type 1 Diabetes (T1D)
| NCT ID | NCT07434544 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical College of Wisconsin |
| Condition | Non-Nutritive Sweetener |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-08-05 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-08-05 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Aged 15-24 years 2. Clinical diagnosis of type 1 diabetes, requiring insulin therapy, of ≥ 1 to \< 10 years duration. 3. 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) 4. Current use of an FDA approved automated insulin delivery (AID) system 5. Willing to consume a 12 ounce Gatorade G Zero Glacier Cherry drink in less than 10 minutes 6. Willing and able to give informed consent or have parent or legal guardian provide informed consent if the subject is \< 18 years of age Exclusion Criteria: 1. Any disease other than type 1 diabetes that affects glucose, sex steroid, or fat metabolism such as polycystic ovary syndrome or hypercortisolism 2. Any medication use that may affect glucose, sex steroid, or fat metabolism such as metformin or glucocorticoids 3. Half or full sibling already participating in this study 4. Known cardiovascular disease such as hypertension or atherosclerosis, and/or use of an anti-hypertensive medication 5. Known hyperlipidemia, defined as LDL ≥ 160 mg/dL, and/or use of lipid-lowering medication, such as statin therapy 6. Known renal disease or microalbuminuria, and/or use of angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blockers (ARBs) for microalbuminuria 7. Known diabetic retinopathy or neuropathy 8. Raynaud's phenomenon or other vascular disease 9. 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. 10. Pregnancy or lactation 11. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07434544 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 24 Years, studying Non-Nutritive Sweetener. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07434544 currently recruiting?
Yes, NCT07434544 is actively recruiting participants. Contact the research team at T1dinfo@mcw.edu for enrollment information.
Where is the NCT07434544 trial being conducted?
This trial is being conducted at Milwaukee, United States.
Who is sponsoring the NCT07434544 clinical trial?
NCT07434544 is sponsored by Medical College of Wisconsin. The trial plans to enroll 20 participants.