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

NCT05215964 | Unknown

• 1 other identifier: 202006139RINA
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Kidney Diseases; Polycystic Liver Disease; Muscle Loss

Outcome Measures

Primary Outcomes (1)

• Total psoas muscle change

  The change of psoas muscle area before and after procedures.

  6 months by imaging study

Secondary Outcomes (1)

• Total kidney volume change

  6 months by imaging study

Study Arms (1)

TAE arm

Patients will receive TAE

Procedure: Renal artery embolization

Interventions

Renal artery embolization PROCEDURE

After catheterization of renal arteries, multiple coils are applied to embolize renal arteries until blood flow stasis

TAE arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Lack of Bio-exam or medical images
• Pregnancy

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

NTUH

Taipei, 100226, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

hemogram, complete blood count, CBC renal function: BUN, Cr electrolytes: Na, K, Ca, P hypertension: plasma renin activity, aldosterone inflammation: CRP, IL-6、TNF-α、IL-1 liver function: AST, ALT, Albumin, T-Bil, PT, INR muscle: CPK, myostatin adipose: Cholesterol, TG, HDL, LDL, adiponectin

MeSH Terms

Conditions

Polycystic Kidney Diseases; Polycystic liver disease; Muscular Atrophy

Condition Hierarchy (Ancestors)

Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Ared Wu, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: January 31, 2022
• Study Start: September 29, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: January 31, 2022

Record last verified: 2021-10

Locations

TW (1)