Chronic Kidney Disease - Stage VMODAIRNCT02902705
Adipose Tissue & Uremia
A study testing Biopsy of abdominal subcutaneous white adipose tissue (2-3 g) in people with Chronic Kidney Disease - Stage V, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Many metabolic disturbances, such as protein-energy wasting, inulin resistance, and dyslipidemia are common features of chronic kidney disease (CKD). However, to date, the underlying mechanisms of these disturbances remain elusive. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Chronic Kidney Disease - Stage V
- What is being tested?
- Biopsy of abdominal subcutaneous white adipose tissue (2-3 g)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2009to Jul 2015
- Phase
- Interventional
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CKD (Chronic Kidney Disease) and non-CKD patients:
- At least 18 years of age
- Able and willing to provide informed consent
- Male gender
- Normal fasting glucose (less than 6 mmol/l )
- No evidence of significant concurrent illness
Show all 13Show fewer
- BMI <30 kg/m2
- Non acidotic (bicarbonate >20 mmol/L)
- Normal coagulation profile
- CKD patients:
- eGFR (estimated Glomerular Filtration Rate)< 25 mL/min/m2 before the beginning of renal suppletion therapy
- Non-CKD patients:
- eGFR >50 mL/min/m2
Who cannot join
- A known diagnosis of diabetes mellitus
- enrolled in a other study that may confound results of this study.
- Have been treated with: corticosteroids or insulin or oral diabetic medications within 8 days prior to study entry
- Unwilling and/or not able to give written consent
- Patient with active systemic bacterial, viral or fungal infections
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Néphrologie, dialyse, hypertension artérielle - Pavillon P - Hôpital Edouard Herriot -
Lyon, 69003
About this study
Official title: Morphological and Functional Changes in White Adipose Tissue in Nondiabetic Chronic Kidney Disease Patients
Many metabolic disturbances, such as protein-energy wasting, inulin resistance, and dyslipidemia are common features of chronic kidney disease (CKD). However, to date, the underlying mechanisms of these disturbances remain elusive. Many in vitro studies have demonstrated that white adipose cells exhibit dysfunctions in conditions that mimics uremic environment. In good agreement, several animal experiments have reported that chronic kidney disease was associated with lipoatrophy, adipose tissue dysfunction and ectopic lipid redistribution. The goal of this protocol is to collect and study structural and metabolic properties of white adipose tissue in CKD stage V patients to evidence adipose tissue dysfunction associated with CKD. The primary outcome measure will be the cellularity of the adipose tissue (i.e. size of the adipose cells) and the secondary measure to study the gene expression profile using microarray and metabolic properties of adipose tissue (i.e. lipogenesis). To this end, 15 male adult volunteers and 15 non-diabetic and non-dialyzed CKD stage V patients, matched for age, gender and body mass index (BMI) will be recruited at the Departments of Nephrology or Urology of Lyon University Hospital (Lyon, France). The biopsies of abdominal subcutaneous white adipose tissue (2-3 g) will be performed during elective urologic surgery (i.e. peritoneal dialysis catheter for CKD patients and radical prostatectomy for non CKD patients).
- Conditions
- Chronic Kidney Disease - Stage V
- Being tested
- Biopsy of abdominal subcutaneous white adipose tissue (2-3 g)
- Keywords
- White adipose tissue, chronic kidney disease, uremia, adipocytes
- Medical subject headings
- Renal Insufficiency, Chronic, Uremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy of abdominal subcutaneous white adipose tissue (2-3 g)Other
The biopsies of abdominal subcutaneous white adipose tissue (2-3 g) will be performed during elective surgery (i.e. peritoneal dialysis catheter) for CDK patients or during elective urologic surgery (e.g. radical prostatectomy) for Non-CDK patients. 50-100 mg will fixed in osmium tetroxide for cellularity measurement and 1g of fresh adipose tissue were used from adipocyte isolation. The remnant part of the biopsies will be snap frozen in liquid nitrogen and stored at -80°C until use (gene expression).
| Study group | Role | What they receive |
|---|---|---|
| Chronic Kidney disease patients - stage V | Experimental | Male adults non-diabetic and non-dialyzed CKD stage 5 patients. All the CKD patient will be recruited at the Department of Nephrology of Edouard Herriot University Hospital (Lyon, France). Receives: Other: Biopsy of abdominal subcutaneous white adipose tissue (2-3 g) |
| Non Chronic Kidney Disease patients | Other | Non CKD male adults matched for age, gender and body mass index (BMI) with CKD patients. All the non - CKD patient will recruited from Department of recruited at the Department of Urology of Edouard Herriot University Hospital (Lyon, France). Receives: Other: Biopsy of abdominal subcutaneous white adipose tissue (2-3 g) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean adipocyte size (in µm) in subcutaneous white adipose tissue removed during biopsy, measured with a Beckman Coulter
The biopsies of abdominal subcutaneous white adipose tissue (2-3 g) will be performed during elective surgery (i.e. peritoneal dialysis catheter for CKD patients and radical prostatectomy for non CKD patients). 50-100 mg will be fixed in osmium tetroxide for cellularity measurement i.e. measurement of adipose cell size. Adipose cell size will be determined by a Beckman Coulter Multisizer IV (Beckman Coulter) with a 400 µm aperture. The range of cell sizes that can effectively be measured using this aperture is 20-240 µm. The instrument will be set to count 1,000 particles, and the fixed-cell suspension will be diluted so that coincident counting remains <10%. Cell-size distributions will be drawn from measurement of at least 12,000 cell diameters for each patient. The mean fat cell volume will then be compared using Student t test or Mann \& Whitney U tests.
Measured: Day 1, the day of surgery (one day after inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startSep 2009
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease - Stage VStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902705
- Sponsor's protocol ID
- 2008.520
- Acronym
- MODAIR
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2016
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Luce M, Barba C, Yi D, Mey A, Roussel D, Bres E, Benoit B, Pastural M, Granjon S, Szelag JC, Laville M, Arkouche W, Bouchara A, Nyam E, Fouque D, Soulage CO, Koppe L. Accumulation of natriuretic peptides is associated with protein energy wasting and activation of browning in white adipose tissue in chronic kidney disease. Kidney Int. 2020 Sep;98(3):663-672. doi: 10.1016/j.kint.2020.03.027. Epub 2020 Apr 23.
PubMed 32739210
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological and Functional Changes in White Adipose Tissue in Nondiabetic Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT02902705
- Acronym / sponsor ID
- MODAIR / 2008.520
- Conditions
- Chronic Kidney Disease - Stage V
- Keywords
- White adipose tissue, chronic kidney disease, uremia, adipocytes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 16 Sep 2016 (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.
Many metabolic disturbances, such as protein-energy wasting, inulin resistance, and dyslipidemia are common features of chronic kidney disease (CKD). However, to date, the underlying mechanisms of these disturbances remain elusive. Many in vitro studies have demonstrated that white adipose cells exhibit dysfunctions in conditions that mimics uremic environment. In good agreement, several animal experiments have reported that chronic kidney disease was associated with lipoatrophy, adipose tissue dysfunction and ectopic lipid redistribution. The goal of this protocol is to collect and study structural and metabolic properties of white adipose tissue in CKD stage V patients to evidence adipose tissue dysfunction associated with CKD. The primary outcome measure will be the cellularity of the adipose tissue (i.e. size of the adipose cells) and the secondary measure to study the gene expression profile using microarray and metabolic properties of adipose tissue (i.e. lipogenesis). To this end, 15 male adult volunteers and 15 non-diabetic and non-dialyzed CKD stage V patients, matched for age, gender and body mass index (BMI) will be recruited at the Departments of Nephrology or Urology of Lyon University Hospital (Lyon, France). The biopsies of abdominal subcutaneous white adipose tissue (2-3 g) will be performed during elective urologic surgery (i.e. peritoneal dialysis catheter for CKD patients and radical prostatectomy for non CKD patients).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Kidney disease patients - stage V | Experimental | Other: Biopsy of abdominal subcutaneous white adipose tissue (2-3 g)Male adults non-diabetic and non-dialyzed CKD stage 5 patients. All the CKD patient will be recruited at the Department of Nephrology of Edouard Herriot University Hospital (Lyon, France). |
| Non Chronic Kidney Disease patients | Other | Other: Biopsy of abdominal subcutaneous white adipose tissue (2-3 g)Non CKD male adults matched for age, gender and body mass index (BMI) with CKD patients. All the non - CKD patient will recruited from Department of recruited at the Department of Urology of Edouard Herriot University Hospital (Lyon, France). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- At least 18 years of age
- Able and willing to provide informed consent
- Male gender
- Normal fasting glucose (less than 6 mmol/l )
- No evidence of significant concurrent illness
Key exclusion criteria (5 listed)
- A known diagnosis of diabetes mellitus
- enrolled in a other study that may confound results of this study.
- Have been treated with: corticosteroids or insulin or oral diabetic medications within 8 days prior to study entry
- Unwilling and/or not able to give written consent
- Patient with active systemic bacterial, viral or fungal infections
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 |
|---|---|---|
| Biopsy of abdominal subcutaneous white adipose tissue (2-3 g)The biopsies of abdominal subcutaneous white adipose tissue (2-3 g) will be performed during elective surgery (i.e. peritoneal dialysis catheter) for CDK patients or during elective urologic surgery (e.g. radical prostatectomy) for Non-CDK patients. 50-100 mg will fixed in osmium tetroxide for cellularity measurement and 1g of fresh adipose tissue were used from adipocyte isolation. The remnant part of the biopsies will be snap frozen in liquid nitrogen and stored at -80°C until use (gene expression). | Other | Chronic Kidney disease patients - stage V, Non Chronic Kidney Disease patients |
Primary outcome
Mean adipocyte size (in µm) in subcutaneous white adipose tissue removed during biopsy, measured with a Beckman Coulter
Time frame: Day 1, the day of surgery (one day after inclusion)
The biopsies of abdominal subcutaneous white adipose tissue (2-3 g) will be performed during elective surgery (i.e. peritoneal dialysis catheter for CKD patients and radical prostatectomy for non CKD patients). 50-100 mg will be fixed in osmium tetroxide for cellularity measurement i.e. measurement of adipose cell size. Adipose cell size will be determined by a Beckman Coulter Multisizer IV (Beckman Coulter) with a 400 µm aperture. The range of cell sizes that can effectively be measured using this aperture is 20-240 µm. The instrument will be set to count 1,000 particles, and the fixed-cell suspension will be diluted so that coincident counting remains <10%. Cell-size distributions will be drawn from measurement of at least 12,000 cell diameters for each patient. The mean fat cell volume will then be compared using Student t test or Mann \& Whitney U tests.
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 9 Sep 2025.
- Results publication: PubMed 32739210Luce M, Barba C, Yi D, Mey A, Roussel D, Bres E, Benoit B, Pastural M, Granjon S, Szelag JC, Laville M, Arkouche W, Bouchara A, Nyam E, Fouque D, Soulage CO, Koppe L. Accumulation of natriuretic peptides is associated with protein energy wasting and activation of browning in white adipose tissue in chronic kidney disease. Kidney Int. 2020 Sep;98(3):663-672. doi: 10.1016/j.kint.2020.03.027. Epub 2020 Apr 23.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy of abdominal subcutaneous white adipose tissue (2-3 g) in people with Chronic Kidney Disease - Stage V, run by Hospices Civils de Lyon at 1 site in France.
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 13 inclusion and 5 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 9 Sep 2025. 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 France. 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 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?
Mean adipocyte size (in µm) in subcutaneous white adipose tissue removed during biopsy, measured with a Beckman Coulter (time frame: Day 1, the day of surgery (one day after inclusion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02902705, which also lists 1 linked publication.
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 9 Sep 2025.