Comparative investigation of hepatic and renal anatomy using a deep penetrating versus standard ultrasound probe in an obese populatio

• Conditions: E66.0; Obesity due to excess calories

• Registration Number: DRKS00023498
• Lead Sponsor: Helmholtz-Institut für Metabolismus-, Adipositas und Gefäßforschung (HI-MAG), Leipzig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-09
• Study Completion: 2022-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Written informed consent
- Abilty to have an ultrasound exam performed
- age = 18 years

Subcohorts
Group 1: Individuals with overweight (body mass index, BMI, 25-29,9 kg/m2)
Group 2: Individuals with obesity, grade I (BMI 30-34,9 kg/m2)
Group 3: Individuals with obesity, grade II (BMI 35-39,9 kg/m2)
Group 4: Individuals with obesity, grade III (BMI = 40 kg/m2)
Group 5: non-obese/overweight individuals (BMI 18,5-24,9 kg/m2), physiologic hepatic and right renal ultrasound anatomy, no diseases with respect to the abdomen

Exclusion Criteria

- Pregnancy/lactating
- Altered liver anatomy, e.g. due to surgery
- Altered right renal anatomy, e.g. due to surgery
- Aczites, peri-hepatic
- History of complex abdominal surgery
- Meteorism in area of investigation

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of liver and renal (right kidney) ultrasound imaging and anatomy in individuals with overweight/obesity grade I-III (groups 1-4) versus non-obese/overweight individuals (group 5) using bioacoustic imagine (ultrasound probe 1) versus standard-of-care, high end ultrasound probes (probe 2: Siemens Convex High-End Routine; probe 3: Canon 8CX1).

Secondary Outcome Measures

Name	Time	Method
- Semiquantitative analysis of heaptic steatosis comparing probe 1 versus 2 and 3 in groups 1-4.<br>- Comparison of hepatic image quality using probe 1 versus 2 and 3 in groups 1-5.<br>- Assessment of right renal anatomy comparing probe 1 versus 2 and 3.<br>- Assessment of hepatic and renal vessels comparing probe 1 versus 2 and 3 in groups 1-5.<br>- Comparison of shear-wave-elastography results using probe 1 and 2 relative to FibroScan.<br>- Comparison of visualization of structures within the liver phantom using probe 1 versus 2 and 3.<br>- Comparison of liver phantom image quality using probe 1 versus 2 and 3.