Muscle in Obesity: Imaging, Function and microRNA

November 15, 2023 updated by: Sheffield Teaching Hospitals NHS Foundation Trust

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom
        • University of Sheffield/Sheffield Teaching Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy Caucasian Women Recruited from around South Yorkshire and Merseyside, UK

Description

Inclusion criteria:

  • 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

Exclusion Criteria:

  • 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

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: observational study
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
Other: observational study
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
Other: observational study
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
Other: observational study
observational study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1 day (one measurement )

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 )
6 Minute walk test
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 )
MRI (Magnetic Resonance Imaging)
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 )
DXA (dual energy X-ray absorptiometry)
1 day (one measurement )
mean difference in muscle strength between normal weight and obese, further stratified by dynapenia
Time Frame: 1 day (one measurement )
Isokinetic dynamometer
1 day (one measurement )
mean difference in fatigue between normal weight and obese, further stratified by dynapenia
Time Frame: 1 day (one measurement )
kinetic change in gait parameters from Opal accelerometers
1 day (one measurement )

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sheffield Teaching Hospitals NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Sheffield
University of Liverpool

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer Walsh, University of Sheffield

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 17, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 17, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STH21022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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