UremiaNCT07086430
Independent Effects of Visceral Adipose Volume and Density on Patient Survival in Peritoneal Dialysis
An observational study of Uremia and End Stage Renal Disease on Dialysis, run by RenJi Hospital.
Trial summary
It was VAT volume predict patient outcome, while VAT density predicted baseline membrane function in PD patients and reflected peritoneal vascular density and local inflammation status. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Uremia, End Stage Renal Disease on Dialysis
- How many people
- 358 participants
- Where
- No sites listed yet
- Study dates
- 21 Jul 2015to May 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study included peritoneal dialysis patients follow up in our center who had an abdominal CT scan within 2 weeks before PD catheter incubation. Those with acute inflammation according to clinical signs, lab results or abdominal CT scan were excluded from the cohort. In early years, abdominal CT scan was done if the patient reported history of abdominal abnormalities, such as history of cholelithiasis. Since 2020 it became a routine check before PD catheter incubation in our center. Those with cholelithiasis or hernia were suggested to had the preventive operation at the time of PD catheter incubation under general anesthesia. The patients started PD within 4 weeks after catheter incubation. A validation cohort was from a satellite center of the hospital. The inclusion criteria were same as the derivation cohort.
Who may be able to join
- The study included peritoneal dialysis patients follow up in our center who had an abdominal CT scan within 2 weeks before PD catheter incubation.
Who cannot join
- Those with acute inflammation according to clinical signs, lab results or abdominal CT scan were excluded from the cohort.
About this study
It was VAT volume predict patient outcome, while VAT density predicted baseline membrane function in PD patients and reflected peritoneal vascular density and local inflammation status.
- Conditions
- Uremia, End Stage Renal Disease on Dialysis
- Keywords
- peritoneal dialysis, fat attenuation index on CT
- Medical subject headings
- Uremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| derivation cohort; validation cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the association between peritoneal membrane solute transfer rate and abdominal visceral adipose tissue density measured on CT
Measured: from the baseline, 4 weeks before PD catheter insert surgery until patients quit PD or follow up up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start21 Jul 2015
- Primary completion11 Jul 2023
- Study completionMay 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UremiaStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yue Qian, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086430
- Sponsor's protocol ID
- LY2025-017-B
- Status last verified
- Apr 2025
- First submitted
- 14 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Independent Effects of Visceral Adipose Volume and Density on Patient Survival in Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT07086430
- Acronym / sponsor ID
- LY2025-017-B
- Conditions
- Uremia, End Stage Renal Disease on Dialysis
- Keywords
- peritoneal dialysis, fat attenuation index on CT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 21 Jul 2015 (actual)
- Primary completion
- 11 Jul 2023 (actual)
- Study completion
- May 2025 (actual)
- First posted
- 25 Jul 2025 (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.
It was VAT volume predict patient outcome, while VAT density predicted baseline membrane function in PD patients and reflected peritoneal vascular density and local inflammation status.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| derivation cohort; validation cohort | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study included peritoneal dialysis patients follow up in our center who had an abdominal CT scan within 2 weeks before PD catheter incubation. Those with acute inflammation according to clinical signs, lab results or abdominal CT scan were excluded from the cohort. In early years, abdominal CT scan was done if the patient reported history of abdominal abnormalities, such as history of cholelithiasis. Since 2020 it became a routine check before PD catheter incubation in our center. Those with cholelithiasis or hernia were suggested to had the preventive operation at the time of PD catheter incubation under general anesthesia. The patients started PD within 4 weeks after catheter incubation. A validation cohort was from a satellite center of the hospital. The inclusion criteria were same as the derivation cohort.
Key inclusion criteria (1 listed)
- The study included peritoneal dialysis patients follow up in our center who had an abdominal CT scan within 2 weeks before PD catheter incubation.
Key exclusion criteria (1 listed)
- Those with acute inflammation according to clinical signs, lab results or abdominal CT scan were excluded from the cohort.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the association between peritoneal membrane solute transfer rate and abdominal visceral adipose tissue density measured on CT
Time frame: from the baseline, 4 weeks before PD catheter insert surgery until patients quit PD or follow up up to 48 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Uremia and End Stage Renal Disease on Dialysis, run by RenJi Hospital.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the association between peritoneal membrane solute transfer rate and abdominal visceral adipose tissue density measured on CT (time frame: from the baseline, 4 weeks before PD catheter insert surgery until patients quit PD or follow up up to 48 months). 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 25 Jul 2025.