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Recruiting
NCT07434544
Cardiometabolic Effects of Non-Nutritive Sweeteners (NNS) in Type 1 Diabetes (T1D)
Conditions: Non-Nutritive Sweetener, Type 1 Diabetes, type1diabetes, Type 1 Diabetes Mellitus
Sex: All
Ages: 15 Years – 24 Years
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Medical College of Wisconsin
Location: Medical College of Wisconsin Milwaukee Wisconsin
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.
Source: ClinicalTrials.gov (NCT07434544). StuddyBuddy aggregates publicly available trial information.