Muscle FunctionNCT04300504
Muscle in Obesity: Imaging, Function and microRNA
An observational study of Muscle Function, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Growing evidence suggests that dynapenic abdominal obesity is associated with a greater risk of falls, functional disability and hospitalisation compared to those with dynapenia, obesity or neither phenotype. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Function
- What is being tested?
- observational study
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2021to 17 Mar 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 60 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Caucasian Women Recruited from around South Yorkshire and Merseyside, UK
Who may be able to join
- Caucasian
- Female
- BMI 18.5-25 or 30-40kg/m2
- Ages 60-80 years
- Sufficiently mobile to undergo scanning and biomechanical testing
- Able to remain motionless during scans
- Able and willing to participate in the study and provide written informed consent
Who cannot join
- BMI 18.5-25kg/m2 AND waist circumference >88cm i.e. normal weight AND abdominally obese
- BMI 30-40kg/m2 AND waist circumference <88cm i.e. obese AND not abdominally obese
- History of any long-term immobilisation (duration greater than 2 weeks in the past 12 months)
- History of hospital admission in the past 3 months
- History of recent significant weight loss (5% in 3 months or 10% in 6 months)
- Diabetes mellitus
Show all 17Show fewer
- History of current conditions which may affect muscle metabolism
- Malabsorption syndromes e.g. inflammatory bowel disease, pancreatic insufficiency etc.
- Chronic renal disease
- Diagnosed eating disorder
- Conditions which prevent the undertaking or analysis of the MRI and DXA scans or the interpretation of their results e.g. hip prosthesis, metal implants etc.
- Conditions which prevent the undertaking of the fatigue protocols e.g. hypertension etc.
- Use of medications or treatment known to affect muscle metabolism
- o Anabolic steroids, glucocorticoids, antiretrovirals etc.
- Excessive alcohol intake defined as greater than 21 units per week
- Competitive athlete, defined as participating in competitive sport at amateur or professional level
- Conditions which prevent the undertaking of a 6-minute walking test e.g. unstable angina or myocardial infarction during the previous month.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Sheffield/Sheffield Teaching Hospitals
Sheffield, South Yorkshire
About this study
Growing evidence suggests that dynapenic abdominal obesity is associated with a greater risk of falls, functional disability and hospitalisation compared to those with dynapenia, obesity or neither phenotype. Understanding the pathogenesis underlying this phenotype has the potential to inform potential treatment strategies.
MicroRNAs can act as messengers at the cellular level to promote or block processes for muscle growth and repair, amongst other things. There is evidence that ageing changes microRNA levels in the muscle and that these changes may result in reduced muscle quality and quantity. However, it is not known whether being obese can change microRNA levels in muscle and how this relates to physical performance.
Read more
The aim of this study is to investigate the effect of dynapenic abdominal obesity on microRNA levels in serum and muscle quality and quantity in the legs of older women.
This is an observational, cross-sectional study. The investigators will recruit 4 groups of older women: normal weight, normal weight with dynapenia, obese and obese with dynapenia. The investigators will measure the microRNA levels in serum. The investigators will measure the quantity and fat content of muscle in the legs using magnetic resonance imaging. Muscle strength, fatigue and balance will be measured using gait (walking) analysis, balance tests, and a machine designed to measure leg strength and fatigue.
The investigators will measure and compare microRNA levels between groups. The investigators will use databases and computer programmes to look at all of the microRNAs which are different between groups and see how they affect the muscle. The investigators will compare muscle strength, size and fatigue between groups. The investigators will explore relationships of muscle quantity and quality measures with microRNA changes in the muscle. This approach will allow the investigators to understand how obesity affects the microRNA profile of muscle and whether this translates into impairment of function and mobility.
- Conditions
- Muscle Function
- Being tested
- observational study
- Keywords
- obesity, sarcopenia, dynapenia, microRNA
- Medical subject headings
- Obesity, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
observational study
| Study group | Role | What they receive |
|---|---|---|
| normal weight, not dynapenic | BMI 18.5 to 25kg/m2, waist circumference <= 88cm, healthy women aged 60-80 years, time to complete 5 chair stands <15 seconds Receives: Other: observational study | |
| normal weight, dynapenic | BMI 18.5 to 25kg/m2, waist circumference <= 88cm,healthy women aged 60-80 years, time to complete 5 chair stands >15 seconds Receives: Other: observational study | |
| obese, not dynapenic | BMI 30 to 40kg/m2, waist circumference > 88cm, healthy women aged 60-80 years, time to complete 5 chair stands <15 seconds Receives: Other: observational study | |
| obese, dynapenic | BMI 30 to 40kg/m2, waist circumference > 88cm, women aged 60-80 years, time to complete 5 chair stands >15 seconds Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential microRNA expression, expressed as fold-change and p-values, measured using real time quantitative polymerase chain reaction (RT-qPCR) between normal weight and obese groups, further stratified by dynapenia
Serum analyses
Measured: 1 day (one measurement )
Secondary outcomes (5)
mean difference in distance walked during 6 minute walk test between normal weight and obese, further stratified by dynapenia
6 Minute walk test
Measured: 1 day (one measurement )
mean difference in muscle mass and volume measures between normal weight and obese, further stratified by dynapenia MRI
MRI (Magnetic Resonance Imaging)
Measured: 1 day (one measurement )
mean difference in muscle mass and volume measures between normal weight and obese, further stratified by dynapenia DXA
DXA (dual energy X-ray absorptiometry)
Measured: 1 day (one measurement )
mean difference in muscle strength between normal weight and obese, further stratified by dynapenia
Isokinetic dynamometer
Measured: 1 day (one measurement )
mean difference in fatigue between normal weight and obese, further stratified by dynapenia
kinetic change in gait parameters from Opal accelerometers
Measured: 1 day (one measurement )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start1 Sep 2021
- Primary completion17 Mar 2023
- Study completion17 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle FunctionStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield, University of Liverpool
- Responsible party
- Sponsor
- Investigators
- Jennifer Walsh, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300504
- Sponsor's protocol ID
- STH21022
- Status last verified
- Nov 2023
- First submitted
- 19 Dec 2019
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle in Obesity: Imaging, Function and microRNA
- ClinicalTrials.gov ID
- NCT04300504
- Acronym / sponsor ID
- STH21022
- Conditions
- Muscle Function
- Keywords
- obesity, sarcopenia, dynapenia, microRNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield, University of Liverpool
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 17 Mar 2023 (actual)
- Study completion
- 17 Mar 2023 (actual)
- First posted
- 9 Mar 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.
Growing evidence suggests that dynapenic abdominal obesity is associated with a greater risk of falls, functional disability and hospitalisation compared to those with dynapenia, obesity or neither phenotype. Understanding the pathogenesis underlying this phenotype has the potential to inform potential treatment strategies.
MicroRNAs can act as messengers at the cellular level to promote or block processes for muscle growth and repair, amongst other things. There is evidence that ageing changes microRNA levels in the muscle and that these changes may result in reduced muscle quality and quantity. However, it is not known whether being obese can change microRNA levels in muscle and how this relates to physical performance.
The aim of this study is to investigate the effect of dynapenic abdominal obesity on microRNA levels in serum and muscle quality and quantity in the legs of older women.
This is an observational, cross-sectional study. The investigators will recruit 4 groups of older women: normal weight, normal weight with dynapenia, obese and obese with dynapenia. The investigators will measure the microRNA levels in serum. The investigators will measure the quantity and fat content of muscle in the legs using magnetic resonance imaging. Muscle strength, fatigue and balance will be measured using gait (walking) analysis, balance tests, and a machine designed to measure leg strength and fatigue.
The investigators will measure and compare microRNA levels between groups. The investigators will use databases and computer programmes to look at all of the microRNAs which are different between groups and see how they affect the muscle. The investigators will compare muscle strength, size and fatigue between groups. The investigators will explore relationships of muscle quantity and quality measures with microRNA changes in the muscle. This approach will allow the investigators to understand how obesity affects the microRNA profile of muscle and whether this translates into impairment of function and mobility.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| normal weight, not dynapenic | – | Other: observational studyBMI 18.5 to 25kg/m2, waist circumference <= 88cm, healthy women aged 60-80 years, time to complete 5 chair stands <15 seconds |
| normal weight, dynapenic | – | Other: observational studyBMI 18.5 to 25kg/m2, waist circumference <= 88cm,healthy women aged 60-80 years, time to complete 5 chair stands >15 seconds |
| obese, not dynapenic | – | Other: observational studyBMI 30 to 40kg/m2, waist circumference > 88cm, healthy women aged 60-80 years, time to complete 5 chair stands <15 seconds |
| obese, dynapenic | – | Other: observational studyBMI 30 to 40kg/m2, waist circumference > 88cm, women aged 60-80 years, time to complete 5 chair stands >15 seconds |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Caucasian Women Recruited from around South Yorkshire and Merseyside, UK
Key inclusion criteria (7 listed)
- Caucasian
- Female
- BMI 18.5-25 or 30-40kg/m2
- Ages 60-80 years
- Sufficiently mobile to undergo scanning and biomechanical testing
Key exclusion criteria (17 listed)
- BMI 18.5-25kg/m2 AND waist circumference >88cm i.e. normal weight AND abdominally obese
- BMI 30-40kg/m2 AND waist circumference <88cm i.e. obese AND not abdominally obese
- History of any long-term immobilisation (duration greater than 2 weeks in the past 12 months)
- History of hospital admission in the past 3 months
- History of recent significant weight loss (5% in 3 months or 10% in 6 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational studyobservational study | Other | normal weight, dynapenic, normal weight, not dynapenic, obese, dynapenic, obese, not dynapenic |
Primary outcome
Differential microRNA expression, expressed as fold-change and p-values, measured using real time quantitative polymerase chain reaction (RT-qPCR) between normal weight and obese groups, further stratified by dynapenia
Time frame: 1 day (one measurement )
Serum analyses
5 secondary outcomes
mean difference in distance walked during 6 minute walk test between normal weight and obese, further stratified by dynapenia
Time frame: 1 day (one measurement )
mean difference in muscle mass and volume measures between normal weight and obese, further stratified by dynapenia MRI
Time frame: 1 day (one measurement )
mean difference in muscle mass and volume measures between normal weight and obese, further stratified by dynapenia DXA
Time frame: 1 day (one measurement )
mean difference in muscle strength between normal weight and obese, further stratified by dynapenia
Time frame: 1 day (one measurement )
mean difference in fatigue between normal weight and obese, further stratified by dynapenia
Time frame: 1 day (one measurement )
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 18 Nov 2023.
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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.
Jennifer Walsh principal investigator
University of Sheffield
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 Muscle Function, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 7 inclusion and 17 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 18 Nov 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 Kingdom. 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?
Differential microRNA expression, expressed as fold-change and p-values, measured using real time quantitative polymerase chain reaction (RT-qPCR) between normal weight and obese groups, further stratified by dynapenia (time frame: 1 day (one measurement )). 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 18 Nov 2023.