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

NCT ID: NCT03889522

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2021-02-25

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Blood draw

Blood will be drawn to assess the following labs: HbA1c, leptin, lipid panel and comprehensive metabolic panel.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

BIA; DXA

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Susanne Cabrera

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

1351723

Identifier Type: -

Identifier Source: org_study_id