Clinical trial NCT05215964: The Association Between Skeletal Muscle Mass and Severity of Polycystic Liver Disease and Polycystic Kidney Disease
Official title: The Association Between Skeletal Muscle Mass and Severity of Polycystic Liver Disease and Polycystic Kidney Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polycystic Kidney Diseases
Polycystic Liver Disease
Muscle Loss
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Retrospective group：participants had done TAE procedures since from January 2015 to July 2020.
2. Prospective group：two groups, 1. willing to receive cysts control procedures, 2. medical images follow up only

Brief summary: Primary sarcopenia is used to describe aging and progressed with the physiologic decline. Secondary sarcopenia is associated many chronic disease, including acquired immune deficiency syndrome, cancer, chronic heart failure, chronic lung disease, liver cirrhosis, chronic kidney disease and rheumatoid arthritis. In the past, nutrition status is evaluated by body mass index, mid-upper -arm circumference and serum albumin. Bioelectrical impedance analysis is also a common method to measured body composition, but bioelectrical impedance analysis will be affected by tissue edema and ascites. In contrast, cross-section imaging, such as computed tomography and magnetic resonance can analyzed abdominal muscle and fat accurately.

Since computed tomography and magnetic resonance imaging can evaluate the severity of polycystic liver and kidney disease. Investigators can use cross section imaging at 3rd lumber level to separate skeletal muscle and fat tissue. Previous studies showed the quantity and quality of abdominal muscle are important prognostic factor after liver transplantation. Besides, chronic kidney disease and receiving renal placement therapy lead protein catabolism and make patients with end stage renal disease have sarcopenia. Finally, patients with polycystic liver and kidney disease have organomegaly, which causes abdominal distention and poor appetite. Therefore, the aim of this study is to observe the association between skeletal muscle mass and the severity of disease and to study whether change in hepatic and renal volumes is associated with change in muscle mass.

Detailed description: The imaging study (CT or MRI) will be performed within one month before the procedure to measure total kidney volume and psoas muscle area.

The procedure will use transcatheter embolization to renal artery. The follow-up imaging study will be performed six months after the procedure to measure total kidney volume and psoas muscle area..

Eligibility criteria: Inclusion Criteria:

* Polycystic related disease with medical images (CT or MRI) diagnosed
* Aged over 20 years

Exclusion Criteria:

* Lack of Bio-exam or medical images
* Pregnancy

Primary outcomes:
measure: Total psoas muscle change
timeFrame: 6 months by imaging study
Secondary outcomes:
measure: Total kidney volume change
timeFrame: 6 months by imaging study
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: NTUH
Study officials:
affiliation: National Taiwan University Hospital
name: Ared Wu, MD
role: PRINCIPAL_INVESTIGATOR
References: