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CompletedNCT06468735Updated Jun 21, 2024

The Relationship Among Sarcopenia, Preperitoneal Fat Thickness and Cholecystectomy

An interventional study of sarcopenia assessment and visceral fat thickness measurement in Sarcopenia and Cholecystectomy, sponsored by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-21.

Sponsored by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
158
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Sarcopenia
  • Cholecystectomy

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Keywords

  • ultrasound
  • Quadriceps
  • gall bladder
  • IsarcoPRM
03

In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.

This study's enrollment of 158 is above the median of 60 across 775 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital is the lead sponsor of 73 studies on the registry; 19 are open to participants now.

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

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Cholecystectomy at least 5 years ago
  • control group; those without cholecystectomy

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
158 participants (actual)

Study arms

  • Experimental
    cholecystectomy

    Ultrasonography-guided assessment of sarcopenia and measurement of visceral, preperitoneal, subcutaneous maximum and subcutaneous minimum fat thickness in cholecystectomised participants

    Diagnostic Test: sarcopenia assessment · Diagnostic Test: visceral fat thickness measurement

  • Experimental
    Control

    Ultrasonography-guided assessment of sarcopenia and measurement of visceral, preperitoneal, subcutaneous maximum and subcutaneous minimum fat thickness in participants without cholecystectomy

    Diagnostic Test: sarcopenia assessment · Diagnostic Test: visceral fat thickness measurement

Interventions

  • Diagnostic testsarcopenia assessment

    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

  • Diagnostic testvisceral fat thickness measurement

    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.

06

What researchers measure

Primary outcomes

  1. STAR values

    \<1.0 for females and \<1.4 for males Quadriceps thickness(mm) /BMI kg/m2

    Time frame: through study completion, an average of 4 months

  2. low grip strength

    \<19 kg for females or \<32 kg for males

    Time frame: through study completion, an average of 4 months

  3. chair stand test duration

    ≥12 seconds

    Time frame: through study completion, an average of 4 months

  4. visceral adipose tissue thickness

    mm

    Time frame: through study completion, an average of 4 months

  5. Subcutaneous maximum fat thickness

    mm

    Time frame: through study completion, an average of 4 months

  6. Subcutaneous minimum fat thickness

    mm

    Time frame: through study completion, an average of 4 months

  7. Preperitoneal fat thickness

    mm

    Time frame: through study completion, an average of 4 months

Secondary outcomes

  1. BMI

    kg/m2

    Time frame: through study completion, an average of 4 months

  2. Waist circumference

    cm

    Time frame: through study completion, an average of 4 months

07

Study locations

1 site
  • Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
    Ankara, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06468735
Lead sponsor
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Responsible party
Semih Sezer (Principal Investigator, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital) — Principal investigator
First posted
Jun 21, 2024
Start date
Mar 20, 2024
Primary completion
Jun 19, 2024
Completion
Jun 19, 2024
Last update
Jun 21, 2024

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 Jun 2024. You cannot join it, but the record below documents what was studied.

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