- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07541677
Investigating the Prevalence and Risk Factors for Sarcopenia Amongst Adults Seeking Treatment for Obesity
Sarcopenia, a condition where individuals lose muscle mass and strength, is associated with poorer health and function. While aging is a well-known cause of sarcopenia, obesity is increasingly recognised as a significant factor. When sarcopenia and obesity occur together, it can result in more severe health problems. This is especially concerning because weight loss, the treatment for obesity, can further reduce muscle mass and potentially worsen the situation. Despite this, it is unknown how common sarcopenia is among people with obesity, as only a few studies have looked into this using the most accurate diagnostic criteria, showing a prevalence of 4-13%.
In this study, the investigators will examine the prevalence of sarcopenia in 300 adults with obesity at a specialized Obesity Center. The investigators expect to find a higher prevalence among Asian participants due to differences in body composition compared to other ethnic groups.
The investigators will also explore various factors that might be linked to sarcopenia in these individuals, such as age, gender, race, body mass index, smoking and alcohol use, medical conditions, medications, physical activity, aerobic capacity, and dietary protein intake. Some of these factors could help in identifying those at risk of sarcopenia and could be targeted for future treatments.
Currently, screening for sarcopenia is not a standard part of routine obesity care as it requires specialized equipment and trained staff. By determining how common sarcopenia is in people with obesity, this study will help healthcare providers better understand the problem and allocate resources effectively. Identifying factors associated with sarcopenia will also help streamline diagnosis and monitoring for those at risk.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Singapore, Singapore
- Recruiting
- Singapore General Hospital
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Contact:
- Sarah Tan Dr, MBBS
- Phone Number: +6581239629
- Email: sarah.tan.y.t@singhealth.com.sg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- body mass index ≥ 27.5kg/m2
- able to provide informed consent.
Exclusion Criteria:
- unable to undergo the physical function tests (handgrip strength testing and chair-stand tests)
- pregnant women
- history of bariatric procedures or surgeries
- on medications for treatment of obesity (glucagon-like peptide 1 receptor agonists, phentermine, naltrexone-bupropion, orlistat)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sarcopenia
Time Frame: Outcome measures will be recorded at baseline only.
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Skeletal muscle mass Skeletal muscle mass measurement will be obtained via bioimpedance analysis using the TANITA MC 780 MA Multi-frequency Segmental Body Composition Analyser.
Low skeletal muscle mass will be defined by percentage of skeletal muscle mass divided by body weight of ≤ 37% in males and ≤ 27.6% in females.
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Outcome measures will be recorded at baseline only.
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Handgrip strength
Time Frame: Outcome measures will be recorded at baseline only.
|
Handgrip strength will be measured using the Jamar handgrip dynamometer.
Two trials will be performed for each hand, and the maximum strength will be used for diagnosis.
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Outcome measures will be recorded at baseline only.
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5-time chair stand test
Time Frame: Outcome measures will be recorded at baseline only.
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Time taken (seconds) to perform 5 sit-to-stand repetitions
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Outcome measures will be recorded at baseline only.
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30-second sit-to-stand test
Time Frame: Outcome measures will be recorded at baseline only.
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Number of sit-to-stand repetitions performed in 30 seconds
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Outcome measures will be recorded at baseline only.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Aerobic capacity
Time Frame: At baseline
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The study will use a validated non-exercise prediction model comprising a physical activity questionnaire to estimate peak oxygen uptake, VO2 milliliter/kg/minute (ml/kg/min).
This simple physical activity questionnaire consists of age, gender, height, weight, estimated maximum heart rate, frequency of exercise, length of time for each workout, intensity of each workout, waistline diameter, and resting heart rate.
It will be self-administered or administered with the assistance of the clinical research coordinator if required.
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At baseline
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Physical activity questionnaire
Time Frame: At baseline
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Number of minutes per week spent on moderate to vigorous physical activity will be recorded
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At baseline
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Dietary questionnaire
Time Frame: At baseline
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72 hour dietary recall questionnaire will be administered and dietary macronutrient composition will be calculated
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At baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- sarcopenicobesity
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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