Clinical trial NCT03889522: The Influence of Non-Caloric Artificial Sweeteners on Youth With Type 1 Diabetes
Official title: The Influence of Non-Caloric Artificial Sweeteners on the Metabolome, Body Composition, and Glycemic Control in Youth With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 21
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Youth receiving care at the Children's Hospital of Wisconsin Diabetes Clinic.

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.


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

Primary outcomes:
measure: Quantify artificial sweetener consumption in youth with type 1 diabetes
timeFrame: Study Duration (1 year)
measure: Examine the relationship between artificial sweeteners and body composition
timeFrame: Study Duration (1 year)
measure: Examine the relationship between artificial sweeteners and kidney function
timeFrame: Study Duration (1 year)
measure: Examine the relationship between artificial sweeteners and liver function
timeFrame: Study Duration (1 year)
measure: Examine the relationship between artificial sweeteners and lipid levels.
timeFrame: Study Duration (1 year)
measure: Examine the relationship between artificial sweeteners and metabolism.
timeFrame: Study Duration (1 year)
measure: Examine the relationship between artificial sweeteners and glycemic control
timeFrame: Study Duration (1 year)
measure: Examine the relationship between artificial sweeteners and glycemic control
timeFrame: Study Duration (1 year)
measure: Examine the relationship between artificial sweeteners and glycemic control
timeFrame: Study Duration (1 year)
measure: Examine the relationship between artificial sweeteners and hemoglobin A1c
timeFrame: Study Duration (1 year)
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: