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

Completed

• Conditions: Type 1 Diabetes Mellitus

• Registration Number: NCT03889522
• Lead Sponsor: Medical College of Wisconsin

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-03-22
• Study First Posted: 2019-03-26
• Study Start: 2019-05-01
• Primary Completion: 2021-02-25
• Study Completion: 2021-02-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1. Males and females aged 5-17 years with a clinical diagnosis of T1D of ≥ 6 months in duration
2. BMI between the 5th and 95th percentile

Exclusion Criteria

1. Presence of severe, active disease that requires the use of chronic medication, with the exception of well-controlled autoimmune thyroiditis/hypothyroidism or celiac disease that is well-controlled on a gluten free diet.
2. Diabetes other than T1D
3. Chronic illness known to affect glucose metabolism
4. Psychiatric impairment, with the exception of well-controlled depression or anxiety, that will affect the ability to participate in the study
5. Female participants of child-bearing age with reproductive potential must not be knowingly pregnant
6. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantify artificial sweetener consumption in youth with type 1 diabetes	Study Duration (1 year)	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
Examine the relationship between artificial sweeteners and kidney function	Study Duration (1 year)	To determine if the level of artificial sweeteners is associated with the serum creatinine level.
Examine the relationship between artificial sweeteners and glycemic control	Study Duration (1 year)	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.)
Examine the relationship between artificial sweeteners and hemoglobin A1c	Study Duration (1 year)	To characterize the relationship between artificial sweetener consumption and measures of glycemic control, as measured by serum HbA1c.
Examine the relationship between artificial sweeteners and body composition	Study Duration (1 year)	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.
Examine the relationship between artificial sweeteners and lipid levels.	Study Duration (1 year)	To characterize the relationship between artificial sweetener consumption and metabolism and the levels of fasting lipids (triglyceride level, HDL, LDL, and total cholesterol).
Examine the relationship between artificial sweeteners and liver function	Study Duration (1 year)	To determine if the level of artificial sweeteners is associated with serum AST and ALT levels
Examine the relationship between artificial sweeteners and metabolism.	Study Duration (1 year)	To characterize the relationship between artificial sweetener consumption and metabolism, as measured by a leptin level.

Trial Locations

Locations (1)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States