Cardiometabolic Effects of Non-Nutritive Sweeteners (NNS) in Type 1 Diabetes (T1D)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-24
SponsorMedical College of Wisconsin
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Cherry Sports Drink
Dietary supplement12 oz bottle (1 1/2 cups) of Gatorade G Zero Glacier Cherry™ Sports Drink
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Treatment GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in "in vivo" endothelial function and vascular stiffness
Brachial artery ultrasound will measure flow-mediated dilation % (FMD%) at baseline and 1 hour after drinking a non-nutritive sweetened sports drink.
Time frame
2 years (duration of study)Secondary outcomes
1
Associations of circulating NNS levels with self-reported food frequency assessments
A food frequency survey has been developed of the most common categories of NNS containing foods and beverages. Participants will complete the food frequency survey to select the frequency by which they consumed a given product and the most common serving size over the past month.
Time frame
2 years (duration of study)2
Impact of chronic NNS dietary consumption on cardiovascular health
Changes 1-hour after NNS consumption from baseline will be measured by carotid-femoral pulse wave velocity, baseline flow velocity, and hyperemic flow velocity
Time frame
2 years (duration of study)3
Impact of chronic NNS dietary consumption on metabolic health
Changes 1-hour after NNS consumption from baseline will be measured by blood lipids, blood glucose, and blood pressure
Time frame
2 years (duration of study)4
Impact of chronic NNS dietary consumption of T1D specific glycemic control
Changes 1-hour after NNS consumption from baseline will be measured by 14-day continuous glucose monitor (CGM) data and 14-day insulin data for total daily dose and % basal insulin
Time frame
2 years (duration of study)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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