Cardiometabolic Effects of Non-Nutritive Sweeteners (NNS) in Type 1 Diabetes (T1D)
The Cardiometabolic Impact of Non-Nutritive Sweeteners in Young Adults With Type 1 Diabetes
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 15 Years to 24 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at how sweeteners with little or no calories relate to heart health and how the body uses sugar and fat. It uses a diet survey and measures sweeteners in the blood in people ages 15–24 with type 1 diabetes.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 15–24 years old.
- You have had type 1 diabetes that needs insulin for at least 1 year but less than 10 years.
- Your latest HbA1c (a measure of average blood sugar) is 8.5% or lower.
- You use an FDA-approved automated insulin delivery system.
- You are willing to drink 12 ounces of Gatorade G Zero Glacier Cherry in less than 10 minutes.
- You can and will agree to join the study. If you are under 18, a parent or legal guardian must give permission.
Who can't join
- You have another disease, or take medicine, that affects how your body handles blood sugar, sex hormones, or fat.
- Your full or half sibling is already in the study.
- You have heart or blood vessel disease, including high blood pressure, artery buildup, or Raynaud's (reduced blood flow to fingers or toes), or take blood pressure medicine.
- You have high LDL (“bad”) cholesterol of 160 mg/dL or more, or take medicine to lower blood fats, such as a statin.
- You have kidney disease or small amounts of protein in your urine, or take an ACE inhibitor or ARB medicine for protein in your urine.
- You have eye or nerve damage caused by diabetes.
- Your body size or shape prevents the arm blood vessel ultrasound test. This generally means a BMI over 40 in adults; the study team decides.
- You are pregnant or breastfeeding, or the study doctor thinks another condition could affect your participation or the study results.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (1)
WI
- Medical College of Wisconsin · Milwaukee, WI 53226Susanne M Cabrera, MD · Principal investigatorMore trials in Milwaukee