Cardiometabolic effects of non-nutritive sweeteners in Type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will use a novel dietary tool to measure non-nutritive sweetener exposure and test how it relates to cardiometabolic health in pediatric and young adult participants with Type 1 diabetes. The study involves consuming a fixed amount of a non-nutritive sweetener–containing beverage and monitoring circulating NNS levels and relevant health outcomes. It aims to provide data that could inform care guidelines for people with Type 1 diabetes who use sugar-free products. The approach combines blood measurements with dietary assessment to explore potential vascular and metabolic effects. No results are available yet; the study is exploratory and hypothesis-generating.

Why it matters

Who can join: the full rules

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.

Where it's running

• Medical College of Wisconsin
  Milwaukee, Wisconsin, United States Recruiting

Study contacts

• Study coordinator: Susanne M Cabrera, MD
• Email: T1dinfo@mcw.edu
• Phone: 414-955-4903

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Semaglutide on body composition in adults with type 1 diabetes and overweight/obesity

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.