Type 1 DiabetesNCT04288063
Skeletal Muscle Health in Children With Type 1 Diabetes
An observational study of Type 1 Diabetes, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Type 1 Diabetes
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2020to 19 Nov 2023
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: Cohort will consist of 25 young, prepubertal and very early pubertal (Tanner stages 1 and 2) children (13 females and 12 males) with early onset T1D
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chemical Fingerprints of Skeletal Muscle Health in Children With Type 1 Diabetes
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.
Read the 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-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.
- Conditions
- Type 1 Diabetes
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Early onset T1D children | 25 young, prepubertal and very early pubertal (Tanner stages 1 and 2) children (13 females and 12 males) with early onset T1D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle mass as measured by D3 creatinine dilution method
Measured: Baseline, 1 year
Secondary outcomes (3)
Physical Activity
Continuously monitor physical activity of step count using a mobile device (Garmin).
Measured: Up to 1 year
Endurance
Measured by a 6 minute walk test of physical activity endurance
Measured: Baseline (Sub-study)
Muscle Strength
Determined by use of dynamometry measurements
Measured: Baseline (Sub-study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start18 Sep 2020
- Primary completion31 Oct 2022
- Study completion19 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pinar Gumus Balikcioglu, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288063
- Sponsor's protocol ID
- Pro00104288
- Status last verified
- Dec 2023
- First submitted
- 26 Feb 2020
- Last updated
- 11 Dec 2023
- 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 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemical Fingerprints of Skeletal Muscle Health in Children With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04288063
- Acronym / sponsor ID
- Pro00104288
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 19 Nov 2023 (actual)
- First posted
- 27 Feb 2020 (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 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.
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-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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early onset T1D children | – | –25 young, prepubertal and very early pubertal (Tanner stages 1 and 2) children (13 females and 12 males) with early onset T1D |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Cohort will consist of 25 young, prepubertal and very early pubertal (Tanner stages 1 and 2) children (13 females and 12 males) with early onset T1D
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in muscle mass as measured by D3 creatinine dilution method
Time frame: Baseline, 1 year
3 secondary outcomes
Physical Activity
Time frame: Up to 1 year
Endurance
Time frame: Baseline (Sub-study)
Muscle Strength
Time frame: Baseline (Sub-study)
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 11 Dec 2023.
- 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.
Pinar Gumus Balikcioglu, MD principal investigator
Duke University
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, run by Duke University 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 5 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 11 Dec 2023. 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?
Change in muscle mass as measured by D3 creatinine dilution method (time frame: Baseline, 1 year). 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 11 Dec 2023.