The Relationship Among Sarcopenia, Preperitoneal Fat Thickness and Cholecystectomy

NCT06468735 | Completed

• 1 other identifier: CholecystectomySarcopenia
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcopenia; Cholecystectomy

Keywords

ultrasound; Quadriceps; gall bladder; IsarcoPRM

Outcome Measures

Primary Outcomes (7)

• 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

• low grip strength

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

  through study completion, an average of 4 months

• chair stand test duration

  ≥12 seconds

  through study completion, an average of 4 months

• visceral adipose tissue thickness

  mm

  through study completion, an average of 4 months

• Subcutaneous maximum fat thickness

  mm

  through study completion, an average of 4 months

• Subcutaneous minimum fat thickness

  mm

  through study completion, an average of 4 months

• Preperitoneal fat thickness

  mm

  through study completion, an average of 4 months

Secondary Outcomes (2)

• BMI

  through study completion, an average of 4 months

• Waist circumference

  through study completion, an average of 4 months

Study Arms (2)

cholecystectomy

EXPERIMENTAL

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

Control

EXPERIMENTAL

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

sarcopenia assessment DIAGNOSTIC_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

Control; cholecystectomy

visceral fat thickness measurement DIAGNOSTIC_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.

Control; cholecystectomy

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital: lead

Study Sites (1)

Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 21, 2024
• Study Start: March 20, 2024
• Primary Completion: June 19, 2024
• Study Completion: June 19, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

TU (1)