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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03889522
• Other study ID #: 1351723
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: February 25, 2021

Study information

• Verified date: May 2022
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 25, 2021
• Est. primary completion date: February 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)