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

NCT03889522 | Completed

• 1 other identifier: 1351723
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (10)

• 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

  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.

  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.

  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

  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).

  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.

  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.

  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.

  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.)

  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.

  Study Duration (1 year)

Interventions

Bioelectrical Impedance Analysis DIAGNOSTIC_TEST

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

Total Body Dual-energy X-ray Absorptiometry DIAGNOSTIC_TEST

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 draw DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Youth receiving care at the Children's Hospital of Wisconsin Diabetes Clinic.

You may qualify if:

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

You may not qualify if:

• 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.
• Diabetes other than T1D
• Chronic illness known to affect glucose metabolism
• Psychiatric impairment, with the exception of well-controlled depression or anxiety, that will affect the ability to participate in the study
• Female participants of child-bearing age with reproductive potential must not be knowingly pregnant
• Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma will be used for metabolomic analyses. Samples will be stored and used until none is left.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: March 26, 2019
• Study Start: May 1, 2019
• Primary Completion: February 25, 2021
• Study Completion: February 25, 2021
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)