Polycystic Kidney DiseasesNCT05215964
The Association Between Skeletal Muscle Mass and Severity of Polycystic Liver Disease and Polycystic Kidney Disease
An observational study of Polycystic Kidney Diseases and Polycystic Liver Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Polycystic Kidney Diseases, Polycystic Liver Disease, Muscle Loss
- What is being tested?
- Renal artery embolization
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Sep 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Polycystic related disease with medical images (CT or MRI) diagnosed
- Aged over 20 years
Who cannot join
- Lack of Bio-exam or medical images
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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..
- Being tested
- Renal artery embolization
- Medical subject headings
- Polycystic Kidney Diseases, Polycystic liver disease, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal artery embolizationProcedure or surgery
After catheterization of renal arteries, multiple coils are applied to embolize renal arteries until blood flow stasis
| Study group | Role | What they receive |
|---|---|---|
| TAE arm | Patients will receive TAE Receives: Procedure: Renal artery embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total psoas muscle change
The change of psoas muscle area before and after procedures.
Measured: 6 months by imaging study
Secondary outcomes (1)
Total kidney volume change
The change of total kidney volume before and after procedures
Measured: 6 months by imaging study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start29 Sep 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ared Wu, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215964
- Sponsor's protocol ID
- 202006139RINA
- Status last verified
- Oct 2021
- First submitted
- 28 May 2021
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Skeletal Muscle Mass and Severity of Polycystic Liver Disease and Polycystic Kidney Disease
- ClinicalTrials.gov ID
- NCT05215964
- Acronym / sponsor ID
- 202006139RINA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAE arm | – | Procedure: Renal artery embolizationPatients will receive TAE |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Polycystic related disease with medical images (CT or MRI) diagnosed
- Aged over 20 years
Key exclusion criteria (2 listed)
- Lack of Bio-exam or medical images
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal artery embolizationAfter catheterization of renal arteries, multiple coils are applied to embolize renal arteries until blood flow stasis | Procedure or surgery | TAE arm |
Primary outcome
Total psoas muscle change
Time frame: 6 months by imaging study
The change of psoas muscle area before and after procedures.
1 secondary outcome
Total kidney volume change
Time frame: 6 months by imaging study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ared Wu, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Kidney Diseases and Polycystic Liver Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total psoas muscle change (time frame: 6 months by imaging study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2022.