Cardiometabolic Effects of Non-Nutritive Sweeteners (NNS) in Type 1 Diabetes (T1D)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cherry Sports Drink.
- Who it may be relevant to
- Registry conditions: Non-Nutritive Sweetener, Type 1 Diabetes, type1diabetes, Type 1 Diabetes Mellitus. Basic parameters: 15 years — 24 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Cardiometabolic Impact of Non-Nutritive Sweeteners in Young Adults With Type 1 Diabetes
Overview
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.
Detailed description
The purpose of this project is to learn how NNS affects the health of the blood vessels.
Type 1 diabetes (T1D) is an autoimmune disease that requires lifelong dependence on prescribed insulin. Scientists know that if an individual has T1D, they are at greater risk of having cardiovascular disease than people who do not have diabetes.
To help manage diabetes, individuals may talk with their doctor about adjusting what they normally eat or drink. Doctors typically ask that individuals avoid foods and drinks with lots of sugar in them. In response to this, individuals might drink diet drinks or eat snacks or other foods that are sugar-free. Sugar-free drinks and foods have NNS which help things taste sweet without impacting their blood glucose.
Concern exists that consuming NNS may make individuals more at risk for developing cardiovascular disease. Although the American Heart Association advises against long-term NNS consumption, about 20% of all beverages consumed by children contain NNS.
Currently, there are no scientifically backed questionnaires to assess how much NNS someone is consuming. As well, there are no commercially available lab tests to determine how much NNS is in someone's blood. This makes it difficult to draw associations or causal relationships between NNS exposure and health outcomes.
By conducting this project, the investigators hope to gain knowledge to potentially inform and revise care guidelines for individuals with T1D and ultimately lead to improved nutritional recommendations and clinical care of children.
Interventions
- Dietary supplement Cherry Sports Drink
12 oz bottle (1 1/2 cups) of Gatorade G Zero Glacier Cherry™ Sports Drink
Primary outcome measures
- Change in "in vivo" endothelial function and vascular stiffness [Time frame: 2 years (duration of study)]
Secondary outcome measures (4)
- Associations of circulating NNS levels with self-reported food frequency assessments [Time frame: 2 years (duration of study)]
- Impact of chronic NNS dietary consumption on cardiovascular health [Time frame: 2 years (duration of study)]
- Impact of chronic NNS dietary consumption on metabolic health [Time frame: 2 years (duration of study)]
- Impact of chronic NNS dietary consumption of T1D specific glycemic control [Time frame: 2 years (duration of study)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Medical College of Wisconsin — Milwaukee
Identifiers
NCT: NCT07434544 · PRO00057293