The Relationship Among Sarcopenia, Preperitoneal Fat Thickness and Cholecystectomy

Sarcopenia Clinical Trial

Official title:

The Relationship Among Sarcopenia, Preperitoneal Fat Thickness and Cholecystectomy: The Good, The Bad and The Ugly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06468735
• Other study ID #: CholecystectomySarcopenia
• Status: Completed
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: June 19, 2024

Study information

• Verified date: June 2024
• Source: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: June 19, 2024
• Est. primary completion date: June 19, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholecystectomy
• Sarcopenia

Intervention

Diagnostic Test:
• sarcopenia 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
• visceral 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.

Locations

Country	Name	City	State
Turkey	Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	STAR values	<1.0 for females and <1.4 for males Quadriceps thickness(mm) /BMI kg/m2	through study completion, an average of 4 months
Primary	low grip strength	<19 kg for females or <32 kg for males	through study completion, an average of 4 months
Primary	chair stand test duration	=12 seconds	through study completion, an average of 4 months
Primary	visceral adipose tissue thickness	mm	through study completion, an average of 4 months
Primary	Subcutaneous maximum fat thickness	mm	through study completion, an average of 4 months
Primary	Subcutaneous minimum fat thickness	mm	through study completion, an average of 4 months
Primary	Preperitoneal fat thickness	mm	through study completion, an average of 4 months
Secondary	BMI	kg/m2	through study completion, an average of 4 months
Secondary	Waist circumference	cm	through study completion, an average of 4 months