End-Stage Renal DiseaseNCT01691196
Inflammation in Peritoneal Dialysis Patients: Effect of Obesity
An observational study of End-Stage Renal Disease and Renal Disease, End-Stage, run by University of Illinois Chicago at 1 site in United States.
Trial summary
Our study addresses the following research question: What is the role of obesity in modulating inflammation and innate immune function, as well as the overall responsiveness of innate immune cells (such as macrophages, neutrophils, and other peripheral leukocytes) in patients undergoing peritoneal dialysis? The… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Renal Disease, Renal Disease, End-Stage, Renal Failure, End-Stage
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Sep 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing peritoneal dialysis
Who may be able to join
- > 18 years; and
- peritoneal dialysis (PD) > 6 months.
Who cannot join
- infectious episode within 4 weeks; and
- using immunosuppressive drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Our study addresses the following research question: What is the role of obesity in modulating inflammation and innate immune function, as well as the overall responsiveness of innate immune cells (such as macrophages, neutrophils, and other peripheral leukocytes) in patients undergoing peritoneal dialysis?
The investigators hypothesize that obesity will lead to increased inflammation in patients undergoing peritoneal dialysis.
Read the detailed description
Chronic inflammation is highly prevalent in ESRD and associated with adverse outcomes. For example, chronic exposure of the peritoneal cavity to PD solution leads to induction of cytokines and other inflammatory mediators, generating peritoneal membrane inflammation which results in functional decline of ultrafiltration. Obesity is characterized by a state of chronic low-grade systemic inflammation stemming from expanded adipose tissue mass. Animal studies from our group and others suggest that obesity is associated with exacerbated prolonged inflammatory responses in the peritoneal cavity. The shifting demographic characteristics of the ESRD population, with a rise in elderly patients and those with obesity, is as a significant challenge for management of dialysis patients. Specifically, a 2-fold increase in the percentage of obese patients in the ESRD population has been reported. The caloric burden of PD glucose-containing solutions adds an additional risk for development or exacerbation of obesity and diabetes in patients using this dialysis modality. Few studies have directly evaluated the association between degree of adiposity and inflammation in PD patients. Data obtained from the proposed experiments will help clarify the connection between obesity and risk factors for cardiovascular and infectious diseases in the PD population. These data will also further our knowledge of the basic pathophysiology of both obesity and ESRD and enhance our understanding of factors involved in successful delivery of PD. Results may lead to enhanced nutritional recommendations for PD patients and/or the use of low-glucose or non-glucose alternatives, with a resultant reduction in local and/or systemic inflammation and CVD and other risk factors.
- Keywords
- Obesity, Peritoneal dialysis, Inflammation, Macrophages, Innate immunity
- Medical subject headings
- Kidney Failure, Chronic, Obesity, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma and dialysate levels of pro-inflammatory and anti-inflammatory molecules
Peritoneal dialysate effluent (PDE) and peripheral blood will be obtained from peritoneal dialysis (PD) subjects. Levels of pro- and anti-inflammatory cytokines, chemokines, adipokines, and acute-phase reactants will be evaluated in PDE and plasma. The ability of peripheral leukocytes to respond to microbial stimuli will be studied using whole blood cultures. We predict percentage of body fat will be significantly associated with higher levels of pro-inflammatory factors both systemically and locally and with reduced ability of peripheral leukocytes to respond to microbial stimuli.
Measured: 24 hours
Secondary outcomes (1)
Peritoneal macrophage subphenotype
The composition of leukocytes from peritoneal dialysate effluent (PDE) will be analyzed to evaluate the absolute and relative amounts of leukocyte subclasses. The phenotype of peritoneal macrophages (pMac) will be evaluated by flow cytometry, by real time RT-PCR, and by measurement of mediators characteristic of each activation type following ex vivo culture. We predict that we will observe a significant shift from an anti- to a pro-inflammatory pMac phenotype as adiposity increases
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2017
- Study completionSep 2017
Why it stopped: Study not initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jerrold S. Levine, University of Illinois Chicago
- Investigators
- Jerrold S Levine, MD, Principal investigator, UICNatalia Litbarg, MD, Principal investigator, UICGiamila Fantuzzi, PhD, Principal investigator, UIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691196
- Sponsor's protocol ID
- 2012-0506
- Other IDs
- Baxter/UIC Ref#2012-04881
- Status last verified
- Oct 2019
- First submitted
- 17 Sep 2012
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation in Peritoneal Dialysis Patients: Effect of Obesity
- ClinicalTrials.gov ID
- NCT01691196
- Acronym / sponsor ID
- 2012-0506
- Keywords
- Obesity, Peritoneal dialysis, Inflammation, Macrophages, Innate immunity
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study not initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 24 Sep 2012 (estimated)
- 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.
Our study addresses the following research question: What is the role of obesity in modulating inflammation and innate immune function, as well as the overall responsiveness of innate immune cells (such as macrophages, neutrophils, and other peripheral leukocytes) in patients undergoing peritoneal dialysis?
The investigators hypothesize that obesity will lead to increased inflammation in patients undergoing peritoneal dialysis.
Detailed description
Chronic inflammation is highly prevalent in ESRD and associated with adverse outcomes. For example, chronic exposure of the peritoneal cavity to PD solution leads to induction of cytokines and other inflammatory mediators, generating peritoneal membrane inflammation which results in functional decline of ultrafiltration. Obesity is characterized by a state of chronic low-grade systemic inflammation stemming from expanded adipose tissue mass. Animal studies from our group and others suggest that obesity is associated with exacerbated prolonged inflammatory responses in the peritoneal cavity. The shifting demographic characteristics of the ESRD population, with a rise in elderly patients and those with obesity, is as a significant challenge for management of dialysis patients. Specifically, a 2-fold increase in the percentage of obese patients in the ESRD population has been reported. The caloric burden of PD glucose-containing solutions adds an additional risk for development or exacerbation of obesity and diabetes in patients using this dialysis modality. Few studies have directly evaluated the association between degree of adiposity and inflammation in PD patients. Data obtained from the proposed experiments will help clarify the connection between obesity and risk factors for cardiovascular and infectious diseases in the PD population. These data will also further our knowledge of the basic pathophysiology of both obesity and ESRD and enhance our understanding of factors involved in successful delivery of PD. Results may lead to enhanced nutritional recommendations for PD patients and/or the use of low-glucose or non-glucose alternatives, with a resultant reduction in local and/or systemic inflammation and CVD and other risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing peritoneal dialysis
Key inclusion criteria (2 listed)
- > 18 years; and
- peritoneal dialysis (PD) > 6 months.
Key exclusion criteria (2 listed)
- infectious episode within 4 weeks; and
- using immunosuppressive drugs
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
Plasma and dialysate levels of pro-inflammatory and anti-inflammatory molecules
Time frame: 24 hours
Peritoneal dialysate effluent (PDE) and peripheral blood will be obtained from peritoneal dialysis (PD) subjects. Levels of pro- and anti-inflammatory cytokines, chemokines, adipokines, and acute-phase reactants will be evaluated in PDE and plasma. The ability of peripheral leukocytes to respond to microbial stimuli will be studied using whole blood cultures. We predict percentage of body fat will be significantly associated with higher levels of pro-inflammatory factors both systemically and locally and with reduced ability of peripheral leukocytes to respond to microbial stimuli.
1 secondary outcome
Peritoneal macrophage subphenotype
Time frame: 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
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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.
Jerrold S Levine, MD principal investigator
UIC
Natalia Litbarg, MD principal investigator
UIC
Giamila Fantuzzi, PhD principal investigator
UIC
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 End-Stage Renal Disease and Renal Disease, End-Stage, run by University of Illinois Chicago at 1 site in United States.
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: withdrawn, as of the sponsor's last update on 29 Oct 2019. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Plasma and dialysate levels of pro-inflammatory and anti-inflammatory molecules (time frame: 24 hours). 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 29 Oct 2019.