Type 1 Diabetes MellitusNCT03889522
The Influence of Non-Caloric Artificial Sweeteners on Youth With Type 1 Diabetes
An observational study of Type 1 Diabetes Mellitus, run by Medical College of Wisconsin at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Bioelectrical Impedance Analysis, Total Body Dual-energy X-ray Absorptiometry and Blood draw
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 25 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Youth receiving care at the Children's Hospital of Wisconsin Diabetes Clinic.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: The Influence of Non-Caloric Artificial Sweeteners on the Metabolome, Body Composition, and Glycemic Control in 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Bioelectrical Impedance Analysis, Total Body Dual-energy X-ray Absorptiometry, Blood draw
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioelectrical Impedance AnalysisDiagnostic test
Also called BIA
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 AbsorptiometryDiagnostic test
Also called DXA
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 drawDiagnostic test
Blood will be drawn to assess the following labs: HbA1c, leptin, lipid panel and comprehensive metabolic panel.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.)
Measured: 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.
Measured: Study Duration (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 May 2019
- Primary completion25 Feb 2021
- Study completion25 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanne Cabrera, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889522
- Sponsor's protocol ID
- 1351723
- Status last verified
- Mar 2026
- First submitted
- 20 Feb 2019
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Non-Caloric Artificial Sweeteners on the Metabolome, Body Composition, and Glycemic Control in Youth With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03889522
- Acronym / sponsor ID
- 1351723
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Youth receiving care at the Children's Hospital of Wisconsin Diabetes Clinic.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioelectrical Impedance AnalysisAlso: BIABIA 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. | Diagnostic test | – |
| Total Body Dual-energy X-ray AbsorptiometryAlso: DXAThe 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. | Diagnostic test | – |
| Blood drawBlood will be drawn to assess the following labs: HbA1c, leptin, lipid panel and comprehensive metabolic panel. | Diagnostic test | – |
Primary outcome
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
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.
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.
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
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).
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.
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.
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.
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.)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantify artificial sweetener consumption in youth with type 1 diabetes (time frame: Study Duration (1 year)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.