Skeletal Muscle Health in Children With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Chemical Fingerprints of Skeletal Muscle Health in Children With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04288063
• Other study ID #: Pro00104288
• Status: Completed
• Start date: September 18, 2020
• Est. completion date: November 19, 2023

Study information

• Verified date: December 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

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-up visit study participant 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. The Garmin Connect app will be downloaded onto the parent or guardian's smartphone or tablet. The study team will create a unique study-specific Duke email (e.g. SMHparticipantXXX@duke.edu) and an assign a unique password for each participant. Passwords will be assigned in accordance with applicable Duke Health password security policy requirements. This email address and password will be used solely for account creation and will not be used for communication. No personal information will be used in the study-specific email or password. Study participants are advised to limit personal identifiers entered into mobile applications/third party software only to those that you wish to voluntarily share with others. Study participant is under no obligation to participate in this phase of the study, as is the case with all research, this sub-study is 100% voluntary.

Measurement of Muscle Strength:

Upper and lower body strength will be measured using tools that give the researchers a snapshot of the strength in specific muscle groups. Participant will be asked to grip or pinch or push or pull against a device that measures the force they generate when doing these tasks, to measure their strength. In addition to muscle strength testing we will be measuring functional endurance by having participant walk for 6 minutes to see how far they can walk in 6 minutes. These measurements will be taken by a physical therapist in coordination with regularly scheduled appointments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: November 19, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in muscle mass as measured by D3 creatinine dilution method		Baseline, 1 year
Secondary	Physical Activity	Continuously monitor physical activity of step count using a mobile device (Garmin).	Up to 1 year
Secondary	Endurance	Measured by a 6 minute walk test of physical activity endurance	Baseline (Sub-study)
Secondary	Muscle Strength	Determined by use of dynamometry measurements	Baseline (Sub-study)