The Association Between Skeletal Muscle Mass and Severity of Polycystic Liver Disease and Polycystic Kidney Disease

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Polycystic Kidney Diseases; Muscle Loss; Polycystic Liver Disease
• Intervention / Treatment: Procedure: Renal artery embolization

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..

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100226
    • NTUH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TAE arm; Patients will receive TAE	Procedure: Renal artery embolization; After catheterization of renal arteries, multiple coils are applied to embolize renal arteries until blood flow stasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total psoas muscle change	The change of psoas muscle area before and after procedures.	6 months by imaging study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total kidney volume change	The change of total kidney volume before and after procedures	6 months by imaging study

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Ared Wu, MD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 29, 2020
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (ACTUAL): January 31, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2022
• Last Update Submitted That Met QC Criteria: January 18, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Urologic Diseases; Congenital Abnormalities; Genetic Diseases, Inborn; Pathological Conditions, Anatomical; Abnormalities, Multiple; Kidney Diseases, Cystic; Ciliopathies; Liver Diseases; Kidney Diseases; Polycystic Kidney Diseases; Cysts
• Other Study ID Numbers: 202006139RINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No