An observational study in Type 1 Diabetes Mellitus, sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Medical College of Wisconsin · Observational
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 21 is below the median of 120 across 748 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Youth receiving care at the Children's Hospital of Wisconsin Diabetes Clinic.
Exclusion Criteria:
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.
Also known as: BIA
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.
Also known as: DXA
Blood will be drawn to assess the following labs: HbA1c, leptin, lipid panel and comprehensive metabolic panel.
Quantify artificial sweetener consumption in youth with type 1 diabetes
To quantify artificial sweetener consumption patterns in a cohort of youth with T1D through novel food frequency questionnaires (Non-caloric artificial sweetener Food Frequency Questionnaire for Food and the Non-caloric artificial sweetener Food Frequency Questionnaire for Beverages) and bioassay
Time frame: Study Duration (1 year)
Examine the relationship between artificial sweeteners and body composition
To characterize the relationship between artificial sweetener consumption and measures of body composition, as measured by bioelectrical impedance analysis and DXA scanning, which provide information on the amount and distribution of fat and muscle in the body.
Time frame: Study Duration (1 year)
Examine the relationship between artificial sweeteners and kidney function
To determine if the level of artificial sweeteners is associated with the serum creatinine level.
Time frame: Study Duration (1 year)
Examine the relationship between artificial sweeteners and liver function
To determine if the level of artificial sweeteners is associated with serum AST and ALT levels
Time frame: Study Duration (1 year)
Examine the relationship between artificial sweeteners and lipid levels.
To characterize the relationship between artificial sweetener consumption and metabolism and the levels of fasting lipids (triglyceride level, HDL, LDL, and total cholesterol).
Time frame: Study Duration (1 year)
Examine the relationship between artificial sweeteners and metabolism.
To characterize the relationship between artificial sweetener consumption and metabolism, as measured by a leptin level.
Time frame: Study Duration (1 year)
Examine the relationship between artificial sweeteners and glycemic control
To characterize the relationship between artificial sweetener consumption and measures of glycemic control, as determined by the presence or absence of microalbuminuria.
Time frame: Study Duration (1 year)
Examine the relationship between artificial sweeteners and glycemic control
To characterize the relationship between artificial sweetener consumption and measures of glycemic control, as measured by total daily insulin dose.
Time frame: Study Duration (1 year)
Examine the relationship between artificial sweeteners and glycemic control
To characterize the relationship between artificial sweetener consumption and measures of glycemic control, as measured by the percentage of time participants are within ideal range for blood glucose levels (as measured by glucose monitors.)
Time frame: Study Duration (1 year)
Examine the relationship between artificial sweeteners and hemoglobin A1c
To characterize the relationship between artificial sweetener consumption and measures of glycemic control, as measured by serum HbA1c.
Time frame: Study Duration (1 year)
Plan to share: No
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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Medical College of Wisconsin