SarcopeniaNCT06468735
The Relationship Among Sarcopenia, Preperitoneal Fat Thickness and Cholecystectomy
A study testing sarcopenia assessment and visceral fat thickness measurement in people with Sarcopenia and Cholecystectomy, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to examine the relationship between sarcopenia and visceral adiposity in participants with and without cholecystectomy. In this way, the long-term effects of cholecystectomy operations, which are commonly performed in the society and thought to be harmless, will be evaluated. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Cholecystectomy
- What is being tested?
- sarcopenia assessment and visceral fat thickness measurement
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2024to 19 Jun 2024
- Phase
- Interventional
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cholecystectomy at least 5 years ago
- control group; those without cholecystectomy
Who cannot join
- Advanced cardiac, hepatic and renal insufficiency,
- active malignancies (currently or within the last one year receiving radiotherapy/chemotherapy),
- rheumatological diseases,
- severe knee, hip and hand osteoarthritis,
- use of any assistive device for walking,
- neuromuscular diseases (motor neuron diseases, polyneuropathies, myasthenia gravis),
- major depression,
- Parkinson's disease, previous stroke, cerebellar diseases and multiple sclerosis were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara
About this study
Official title: The Relationship Among Sarcopenia, Preperitoneal Fat Thickness and Cholecystectomy: The Good, The Bad and The Ugly
The aim of this study was to examine the relationship between sarcopenia and visceral adiposity in participants with and without cholecystectomy.
In this way, the long-term effects of cholecystectomy operations, which are commonly performed in the society and thought to be harmless, will be evaluated.
Read the detailed description
Cholecystectomy is recognized as a harmless operation with low mortality and morbidity and is commonly performed worldwide. The unexplained increase in metabolic disorders such as dyslipidemia, hyperglycemia, non-alcoholic fatty liver disease (NAFLD) and sarcopenia with cholecystectomy in recent studies has led to the need for further investigation of these patients. There are very few studies investigating the relationship among sarcopenia, visceral adiposity and cholecystectomy. In previous studies, BIA or DEXA was used for sarcopenia assessment and non-US methods were used for visceral fat assessment. In our study, we aimed to determine the relationship among sarcopenia, visceral adipose tissue and cholecystectomy by using US, which is an easy, cheap and a valid/reliable method.
A total of 158 community-dwelling patients (aged between 41 to 80 years), including cholecystectomized (N=89) and non-cholecystectomized (N=69) participants from gastroenterology clinics were included.
Sarcopenia assessment The quadriceps muscle thickness (mm) was divided by the BMI to get the sonographic thigh adjustment ratio (STAR) values. Grip strength was assessed using an electronic hand dynamometer on the dominant hand side. Three measurements were obtained from the dominant hand and the maximum value was taken for the analyses. Participants in the chair stand test (CST) were instructed to rapidly rise and fall from a chair five times while keeping their arms folded across their chests. The test was repeated three times, and the mean time was recorded. Together with low STAR values (<1.0 for females and <1.4 for males), having low grip strength (<19 kg for females or <32 kg for males) and/or prolonged CST duration (≥12 seconds) were used to diagnose sarcopenia.
Intraabdominal visceral adipose tissue thickness was calculated by placing the probe 2-cm proximal to the midline of the umbilicus with minimal pressure and measuring the distance from the inner surface of the linea alba to the anterior wall of the abdominal aorta. Subcutaneous maximum fat thickness was measured from the distance between the subcutaneous tissue and the linea alba from the same point. Preperitoneal fat thickness was measured from the distal neighborhood of the xiphoid process, 1.5 cm to the right side of the widest distance between the parietal peritoneum and the linea alba. Minimum subcutaneous fat thickness was calculated as the distance measured from the distal neighborhood of the xiphoid process, measured as the shortest distance between the outer part of the linea alba and the subcutaneous fat tissue.
- Conditions
- Sarcopenia, Cholecystectomy
- Being tested
- sarcopenia assessment, visceral fat thickness measurement
- Keywords
- ultrasound, Quadriceps, gall bladder, IsarcoPRM
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sarcopenia assessmentDiagnostic test
Quadriceps muscle thickness measurement at the midpoint between the anterior superior iliac spine and the upper pole of the patella.
Sarcopenia assessment The quadriceps muscle thickness (mm) was divided by the BMI to get the sonographic thigh adjustment ratio (STAR) values. Grip strength was assessed using an electronic hand dynamometer on the dominant hand side. Three measurements were obtained from the dominant hand and the maximum value was taken for the analyses. Participants in the chair stand test (CST) were instructed to rapidly rise and fall from a chair five times while keeping their arms folded across their chests. The test was repeated three times, and the mean time was recorded. Together with low STAR values (<1.0 for females and <1.4 for males), having low grip strength (<19 kg for females or <32 kg for males) and/or prolonged CST duration (≥12 seconds) were used to diagnose sarcopenia
visceral fat thickness measurementDiagnostic test
Intraabdominal visceral adipose tissue thickness was calculated by placing the probe 2-cm proximal to the midline of the umbilicus with minimal pressure and measuring the distance from the inner surface of the linea alba to the anterior wall of the abdominal aorta. Subcutaneous maximum fat thickness was measured from the distance between the subcutaneous tissue and the linea alba from the same point. Preperitoneal fat thickness was measured from the distal neighborhood of the xiphoid process, 1.5 cm to the right side of the widest distance between the parietal peritoneum and the linea alba. Minimum subcutaneous fat thickness was calculated as the distance measured from the distal neighborhood of the xiphoid process, measured as the shortest distance between the outer part of the linea alba and the subcutaneous fat tissue.
| Study group | Role | What they receive |
|---|---|---|
| cholecystectomy | Experimental | Ultrasonography-guided assessment of sarcopenia and measurement of visceral, preperitoneal, subcutaneous maximum and subcutaneous minimum fat thickness in cholecystectomised participants Receives: Diagnostic Test: sarcopenia assessment; Diagnostic Test: visceral fat thickness measurement |
| Control | Experimental | Ultrasonography-guided assessment of sarcopenia and measurement of visceral, preperitoneal, subcutaneous maximum and subcutaneous minimum fat thickness in participants without cholecystectomy Receives: Diagnostic Test: sarcopenia assessment; Diagnostic Test: visceral fat thickness measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
STAR values
<1.0 for females and <1.4 for males Quadriceps thickness(mm) /BMI kg/m2
Measured: through study completion, an average of 4 months
low grip strength
<19 kg for females or <32 kg for males
Measured: through study completion, an average of 4 months
chair stand test duration
≥12 seconds
Measured: through study completion, an average of 4 months
visceral adipose tissue thickness
mm
Measured: through study completion, an average of 4 months
Subcutaneous maximum fat thickness
mm
Measured: through study completion, an average of 4 months
Subcutaneous minimum fat thickness
mm
Measured: through study completion, an average of 4 months
Preperitoneal fat thickness
mm
Measured: through study completion, an average of 4 months
Secondary outcomes (2)
BMI
kg/m2
Measured: through study completion, an average of 4 months
Waist circumference
cm
Measured: through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start20 Mar 2024
- Primary completion19 Jun 2024
- Study completion19 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semih Sezer, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468735
- Sponsor's protocol ID
- CholecystectomySarcopenia
- Status last verified
- Jun 2024
- First submitted
- 19 Jun 2024
- Last updated
- 21 Jun 2024
- 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 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Among Sarcopenia, Preperitoneal Fat Thickness and Cholecystectomy: The Good, The Bad and The Ugly
- ClinicalTrials.gov ID
- NCT06468735
- Acronym / sponsor ID
- CholecystectomySarcopenia
- Conditions
- Sarcopenia, Cholecystectomy
- Keywords
- ultrasound, Quadriceps, gall bladder, IsarcoPRM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 19 Jun 2024 (actual)
- First posted
- 21 Jun 2024 (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 aim of this study was to examine the relationship between sarcopenia and visceral adiposity in participants with and without cholecystectomy.
In this way, the long-term effects of cholecystectomy operations, which are commonly performed in the society and thought to be harmless, will be evaluated.
Detailed description
Cholecystectomy is recognized as a harmless operation with low mortality and morbidity and is commonly performed worldwide. The unexplained increase in metabolic disorders such as dyslipidemia, hyperglycemia, non-alcoholic fatty liver disease (NAFLD) and sarcopenia with cholecystectomy in recent studies has led to the need for further investigation of these patients. There are very few studies investigating the relationship among sarcopenia, visceral adiposity and cholecystectomy. In previous studies, BIA or DEXA was used for sarcopenia assessment and non-US methods were used for visceral fat assessment. In our study, we aimed to determine the relationship among sarcopenia, visceral adipose tissue and cholecystectomy by using US, which is an easy, cheap and a valid/reliable method.
A total of 158 community-dwelling patients (aged between 41 to 80 years), including cholecystectomized (N=89) and non-cholecystectomized (N=69) participants from gastroenterology clinics were included.
Sarcopenia assessment The quadriceps muscle thickness (mm) was divided by the BMI to get the sonographic thigh adjustment ratio (STAR) values. Grip strength was assessed using an electronic hand dynamometer on the dominant hand side. Three measurements were obtained from the dominant hand and the maximum value was taken for the analyses. Participants in the chair stand test (CST) were instructed to rapidly rise and fall from a chair five times while keeping their arms folded across their chests. The test was repeated three times, and the mean time was recorded. Together with low STAR values (<1.0 for females and <1.4 for males), having low grip strength (<19 kg for females or <32 kg for males) and/or prolonged CST duration (≥12 seconds) were used to diagnose sarcopenia.
Intraabdominal visceral adipose tissue thickness was calculated by placing the probe 2-cm proximal to the midline of the umbilicus with minimal pressure and measuring the distance from the inner surface of the linea alba to the anterior wall of the abdominal aorta. Subcutaneous maximum fat thickness was measured from the distance between the subcutaneous tissue and the linea alba from the same point. Preperitoneal fat thickness was measured from the distal neighborhood of the xiphoid process, 1.5 cm to the right side of the widest distance between the parietal peritoneum and the linea alba. Minimum subcutaneous fat thickness was calculated as the distance measured from the distal neighborhood of the xiphoid process, measured as the shortest distance between the outer part of the linea alba and the subcutaneous fat tissue.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cholecystectomy | Experimental | Diagnostic Test: sarcopenia assessment, Diagnostic Test: visceral fat thickness measurementUltrasonography-guided assessment of sarcopenia and measurement of visceral, preperitoneal, subcutaneous maximum and subcutaneous minimum fat thickness in cholecystectomised participants |
| Control | Experimental | Diagnostic Test: sarcopenia assessment, Diagnostic Test: visceral fat thickness measurementUltrasonography-guided assessment of sarcopenia and measurement of visceral, preperitoneal, subcutaneous maximum and subcutaneous minimum fat thickness in participants without cholecystectomy |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cholecystectomy at least 5 years ago
- control group; those without cholecystectomy
Key exclusion criteria (8 listed)
- Advanced cardiac, hepatic and renal insufficiency,
- active malignancies (currently or within the last one year receiving radiotherapy/chemotherapy),
- rheumatological diseases,
- severe knee, hip and hand osteoarthritis,
- use of any assistive device for walking,
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 |
|---|---|---|
| sarcopenia assessmentQuadriceps muscle thickness measurement at the midpoint between the anterior superior iliac spine and the upper pole of the patella. Sarcopenia assessment The quadriceps muscle thickness (mm) was divided by the BMI to get the sonographic thigh adjustment ratio (STAR) values. Grip strength was assessed using an electronic hand dynamometer on the dominant hand side. Three measurements were obtained from the dominant hand and the maximum value was taken for the analyses. Participants in the chair stand test (CST) were instructed to rapidly rise and fall from a chair five times while keeping their arms folded across their chests. The test was repeated three times, and the mean time was recorded. Together with low STAR values (<1.0 for females and <1.4 for males), having low grip strength (<19 kg for females or <32 kg for males) and/or prolonged CST duration (≥12 seconds) were used to diagnose sarcopenia | Diagnostic test | Control, cholecystectomy |
| visceral fat thickness measurementIntraabdominal visceral adipose tissue thickness was calculated by placing the probe 2-cm proximal to the midline of the umbilicus with minimal pressure and measuring the distance from the inner surface of the linea alba to the anterior wall of the abdominal aorta. Subcutaneous maximum fat thickness was measured from the distance between the subcutaneous tissue and the linea alba from the same point. Preperitoneal fat thickness was measured from the distal neighborhood of the xiphoid process, 1.5 cm to the right side of the widest distance between the parietal peritoneum and the linea alba. Minimum subcutaneous fat thickness was calculated as the distance measured from the distal neighborhood of the xiphoid process, measured as the shortest distance between the outer part of the linea alba and the subcutaneous fat tissue. | Diagnostic test | Control, cholecystectomy |
Primary outcome
STAR values
Time frame: through study completion, an average of 4 months
<1.0 for females and <1.4 for males Quadriceps thickness(mm) /BMI kg/m2
low grip strength
Time frame: through study completion, an average of 4 months
<19 kg for females or <32 kg for males
chair stand test duration
Time frame: through study completion, an average of 4 months
≥12 seconds
visceral adipose tissue thickness
Time frame: through study completion, an average of 4 months
mm
Subcutaneous maximum fat thickness
Time frame: through study completion, an average of 4 months
mm
Subcutaneous minimum fat thickness
Time frame: through study completion, an average of 4 months
mm
Preperitoneal fat thickness
Time frame: through study completion, an average of 4 months
mm
2 secondary outcomes
BMI
Time frame: through study completion, an average of 4 months
Waist circumference
Time frame: through study completion, an average of 4 months
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 21 Jun 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sarcopenia assessment and visceral fat thickness measurement in people with Sarcopenia and Cholecystectomy, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 8 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 21 Jun 2024. 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 Turkey (Türkiye). 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?
STAR values (time frame: through study completion, an average of 4 months). The study lists 7 primary outcomes in all. 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 21 Jun 2024.