NCT04288063Completed
Skeletal Muscle Health in Children With Type 1 Diabetes
Chemical Fingerprints of Skeletal Muscle Health in Children With Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 11 Dec 2023
Brief summary (registry, in English)
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 this study will have a blood sample and a urine sample collected after taking a single dose of a nontoxic chemical called D3-creatine. Their body composition will be measured by a scale like device. Parents of participating children will also be asked to complete a food and activity questionnaire. Participants will be in the study for roughly 12 to 24 months. Enrollment will begin once participant signs the consent form. At the 12 month follow-up visit participants will be asked to wear a Garmin physical activity monitor and use the Garmin Connect mobile app for a period of up to 12 months and take a one time Muscle Strength Measurement test. The greatest risks of this study include the possibility of loss of confidentiality.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 29 (actual)
- First submitted
- 26 Feb 2020
- Start date
- Sept 2020
- Primary completion date
- Oct 2022
- Lead sponsor
- Duke University
- Diseases
- Type 1 diabetes
- NCT number
- NCT04288063
What you commit to
- Study type: Observational
- Participants enrolled: 29
- From Sept 2020 to the primary completion date, Oct 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or recent (within the past month) use of medications affecting IR (oral or inhaled steroids, metformin, thiazolidinediones, or atypical antipsychotics)
Other illness
- Genetic syndrome causing diabetes
Lab values
- Anemia or hemoglobinopathies that could affect HbA1c levels,
Other
- Untreated hypothyroidism
- Proteinuria, which could affect the metabolomic profiling.
- Underweight or recent weight loss.
Who the study is looking for
- 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
Age in the registry: 6 years to 11 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.