Status:
COMPLETED
Skeletal Muscle Health in Children With Type 1 Diabetes
Lead Sponsor:
Duke University
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
6-11 years
Brief Summary
The purpose of this research study is to find out if Type 1 Diabetes (T1D) affects skeletal muscle health and if we can improve glycemic control by improving skeletal muscle health. Participants in th...
Detailed Description
Physical Activity Monitor: This research will look at the relationship of physical activity on skeletal muscle health, by using a Physical Activity Monitor (Garmin vívofit 3): At the 12 month follow-...
Eligibility Criteria
Inclusion
- Type 1 diabetes for at least 3 months (defined by American Diabetes Association criteria, with glutamic acid decarboxylase, islet cell or insulin autoantibodies, and insulin requirement.
- Age ≥6 to 11 (inclusive) years of age
- Tanner stage 1 and 2 (pre-pubertal and early pubertal) to minimize pubertal effects
- Normal weight, overweight and obese children with weight maintenance (no recent significant weight loss or gain). Normal weight will be defined as a BMI between the 5th and 85th percentile; overweight will be defined as a BMI at or above the 85th percentile and below the 95th percentile, obesity will be defined as a BMI at or above the 95th percentile for children of the same age and sex
- Mobile Phone needed for Activity Monitoring device App
Exclusion
- Current or recent (within the past month) use of medications affecting IR (oral or inhaled steroids, metformin, thiazolidinediones, or atypical antipsychotics)
- Genetic syndrome causing diabetes
- Untreated hypothyroidism
- Proteinuria, which could affect the metabolomic profiling.
- Anemia or hemoglobinopathies that could affect HbA1c levels,
- Underweight or recent weight loss.
Key Trial Info
Start Date :
September 18 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 19 2023
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04288063
Start Date
September 18 2020
End Date
November 19 2023
Last Update
December 11 2023
Active Locations (1)
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1
Duke University
Durham, North Carolina, United States, 27705