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CompletedNCT04300504Updated Nov 18, 2023

Muscle in Obesity: Imaging, Function and microRNA

An observational study in Muscle Function, sponsored by Sheffield Teaching Hospitals NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to female participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-18.

Sponsored by Sheffield Teaching Hospitals NHS Foundation Trust · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
30
Ages
60 Years to 80 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Muscle Function

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Keywords

  • obesity
  • sarcopenia
  • dynapenia
  • microRNA
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 30 is below the median of 135 across 1,283 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust is the lead sponsor of 207 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
30 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • 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

  • 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

  • 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

Interventions

  • Otherobservational study

    observational study

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 day (one measurement )

Secondary outcomes

  1. mean difference in distance walked during 6 minute walk test between normal weight and obese, further stratified by dynapenia

    6 Minute walk test

    Time frame: 1 day (one measurement )

  2. mean difference in muscle mass and volume measures between normal weight and obese, further stratified by dynapenia MRI

    MRI (Magnetic Resonance Imaging)

    Time frame: 1 day (one measurement )

  3. mean difference in muscle mass and volume measures between normal weight and obese, further stratified by dynapenia DXA

    DXA (dual energy X-ray absorptiometry)

    Time frame: 1 day (one measurement )

  4. mean difference in muscle strength between normal weight and obese, further stratified by dynapenia

    Isokinetic dynamometer

    Time frame: 1 day (one measurement )

  5. mean difference in fatigue between normal weight and obese, further stratified by dynapenia

    kinetic change in gait parameters from Opal accelerometers

    Time frame: 1 day (one measurement )

07

Study locations

1 site
  • University of Sheffield/Sheffield Teaching Hospitals
    Sheffield, South Yorkshire, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04300504
Lead sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
University of Sheffield, University of Liverpool
Responsible party
Sponsor
First posted
Mar 9, 2020
Start date
Sep 1, 2021
Primary completion
Mar 17, 2023
Completion
Mar 17, 2023
Last update
Nov 18, 2023

Study contacts

Jennifer Walsh
principal investigator · University of Sheffield

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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