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NCT Number: NCT03889522

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: 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.

Other names: DXA

Blood draw

Diagnostic Test

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

Primary outcomes

  1. Quantify artificial sweetener consumption in youth with type 1 diabetes

    Time frame: 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

  2. Examine the relationship between artificial sweeteners and body composition

    Time frame: 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.

  3. Examine the relationship between artificial sweeteners and kidney function

    Time frame: Study Duration (1 year)

    To determine if the level of artificial sweeteners is associated with the serum creatinine level.

  4. Examine the relationship between artificial sweeteners and liver function

    Time frame: Study Duration (1 year)

    To determine if the level of artificial sweeteners is associated with serum AST and ALT levels

  5. Examine the relationship between artificial sweeteners and lipid levels.

    Time frame: 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).

  6. Examine the relationship between artificial sweeteners and metabolism.

    Time frame: Study Duration (1 year)

    To characterize the relationship between artificial sweetener consumption and metabolism, as measured by a leptin level.

  7. Examine the relationship between artificial sweeteners and glycemic control

    Time frame: Study Duration (1 year)

    To characterize the relationship between artificial sweetener consumption and measures of glycemic control, as determined by the presence or absence of microalbuminuria.

  8. Examine the relationship between artificial sweeteners and glycemic control

    Time frame: Study Duration (1 year)

    To characterize the relationship between artificial sweetener consumption and measures of glycemic control, as measured by total daily insulin dose.

  9. Examine the relationship between artificial sweeteners and glycemic control

    Time frame: 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.)

  10. Examine the relationship between artificial sweeteners and hemoglobin A1c

    Time frame: Study Duration (1 year)

    To characterize the relationship between artificial sweetener consumption and measures of glycemic control, as measured by serum HbA1c.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 26, 2019
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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