- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06468735
The Relationship Among Sarcopenia, Preperitoneal Fat Thickness and Cholecystectomy
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey
- Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Cholecystectomy at least 5 years ago
- control group; those without cholecystectomy
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: cholecystectomy
Ultrasonography-guided assessment of sarcopenia and measurement of visceral, preperitoneal, subcutaneous maximum and subcutaneous minimum fat thickness in cholecystectomised participants
|
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
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.
|
|
Experimental: Control
Ultrasonography-guided assessment of sarcopenia and measurement of visceral, preperitoneal, subcutaneous maximum and subcutaneous minimum fat thickness in participants without cholecystectomy
|
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
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
through study completion, an average of 4 months
|
|
low grip strength
Time Frame: through study completion, an average of 4 months
|
<19 kg for females or <32 kg for males
|
through study completion, an average of 4 months
|
|
chair stand test duration
Time Frame: through study completion, an average of 4 months
|
≥12 seconds
|
through study completion, an average of 4 months
|
|
visceral adipose tissue thickness
Time Frame: through study completion, an average of 4 months
|
mm
|
through study completion, an average of 4 months
|
|
Subcutaneous maximum fat thickness
Time Frame: through study completion, an average of 4 months
|
mm
|
through study completion, an average of 4 months
|
|
Subcutaneous minimum fat thickness
Time Frame: through study completion, an average of 4 months
|
mm
|
through study completion, an average of 4 months
|
|
Preperitoneal fat thickness
Time Frame: through study completion, an average of 4 months
|
mm
|
through study completion, an average of 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BMI
Time Frame: through study completion, an average of 4 months
|
kg/m2
|
through study completion, an average of 4 months
|
|
Waist circumference
Time Frame: through study completion, an average of 4 months
|
cm
|
through study completion, an average of 4 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CholecystectomySarcopenia
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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