NCT03889522

The Influence of Non-Caloric Artificial Sweeteners on Youth With Type 1 Diabetes

The Influence of Non-Caloric Artificial Sweeteners on the Metabolome, Body Composition, and Glycemic Control in Youth With Type 1 Diabetes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 21 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The investigators aim to further the understanding of environmental factors that may underlie variations in body composition seen in youth with Type 1 diabetes (T1D). Non-caloric artificial sweeteners, broadly consumed in many individuals with T1D, are a modifiable dietary factor that may be associated with negative health outcomes, particularly those relevant to the future risk of diabetes-related complications. Investigators will measure body composition (the amount of fat and muscle in the body and where the fat is stored) using a bioelectrical impedance analysis machine and DEXA scanner. Blood will be drawn for the following labs: HbA1c, lipid panel, comprehensive metabolic panel and leptin. Participants will also answer questions about their diets and consumption of artificial sweeteners.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Bioelectrical Impedance Analysis	BIA is a radiation-free and clinically accessible measure of body composition \[47, 49\]. An electrode is placed on the youth's extremities and they are asked to sit for 10 minutes. The youth's height and weight is manually inputted and the measure is obtained (approx. 90 seconds to complete). BIA sends a low level of electrical current through the body and measures the impedance to the current based on fat, muscle, bones providing a measure of body composition.
DIAGNOSTIC_TEST	Total Body Dual-energy X-ray Absorptiometry	The DXA total body scan provides measurements of percent body fat, lean and fat free mass throughout the body. Youth lay on a table while the machine moves around them. The process takes about 3 minutes and 20 seconds.
DIAGNOSTIC_TEST	Blood draw	Blood will be drawn to assess the following labs: HbA1c, leptin, lipid panel and comprehensive metabolic panel.

Timeline

• Start date: 2019-05-01
• Primary completion: 2021-02-25
• Completion: 2021-02-25
• First posted: 2019-03-26
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States