- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02902705
Adipose Tissue & Uremia (MODAIR)
September 12, 2016 updated by: Hospices Civils de Lyon
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lyon, France, 69003
- Service de Néphrologie, dialyse, hypertension artérielle - Pavillon P - Hôpital Edouard Herriot -
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
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
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chronic Kidney disease patients - stage V
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).
|
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: Non Chronic Kidney Disease patients
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).
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 1, the day of surgery (one day after inclusion)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
September 12, 2016
First Submitted That Met QC Criteria
September 12, 2016
First Posted (Estimate)
September 16, 2016
Study Record Updates
Last Update Posted (Estimate)
September 16, 2016
Last Update Submitted That Met QC Criteria
September 12, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008.520
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Kidney Disease - Stage V
-
3-C Institute for Social DevelopmentUniversity of North Carolina, Chapel HillCompletedChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Pediatric Kidney Disease | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage V | Chronic Kidney Disease, Stage IV (Severe) | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease, Stage IUnited States
-
liberDi Ltd.Not yet recruiting
-
Stanford UniversityEmory University; Santa Clara Valley Medical CenterCompletedPhysical Activity | Chronic Kidney Disease stage4 | Chronic Kidney Disease Stage VUnited States
-
AbbVie (prior sponsor, Abbott)TerminatedHemodialysis | Chronic Kidney Disease Stage VVenezuela
-
Fondazione SchenaUniversity of BariUnknownChronic Kidney Disease Stage VItaly
-
Alexion PharmaceuticalsCompletedStage V Chronic Kidney DiseaseAustralia, France, Italy, Spain, United Kingdom, Sweden
-
Imperial College LondonNational Institute for Health Research, United Kingdom; Imperial College Healthcare...WithdrawnMyocardial Fibrosis | Heart Failure | End Stage Renal Failure on Dialysis | Chronic Kidney Disease Stage V | Chronic Kidney Disease, Stage IV (Severe)United Kingdom
-
Chulalongkorn UniversityUnknownChronic Kidney Disease, Stage IV (Severe) | Chronic Kidney Disease, Stage VThailand
-
AbbVie (prior sponsor, Abbott)Assign Data Management and Biostatistics GmbHCompletedSecondary Hyperparathyroidism | Chronic Kidney Disease Stage V | Cardiac MorbidityAustria
-
Far Eastern Memorial HospitalActive, not recruitingMetabolic Syndrome | Chronic Disease | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease Stage 3 | Chronic Kidney Disease Stage 4 | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease Stage 1Taiwan
Clinical Trials on Biopsy of abdominal subcutaneous white adipose tissue (2-3 g)
-
Boston Medical CenterCompleted
-
AdventHealth Translational Research InstituteActive, not recruiting
-
Cedars-Sinai Medical CenterNational Institute on Aging (NIA)RecruitingObesity | Healthy LifestyleUnited States
-
Washington University School of MedicineJanssen Scientific Affairs, LLCCompletedAdiposity | HIV I InfectionUnited States
-
Boston Medical CenterCompletedObesity | Type 2 Diabetes MellitusUnited States
-
Maastricht University Medical CenterCompletedNeoplasms | Pulmonary Disease, Chronic Obstructive | Pancreatic Neoplasms | CachexiaNetherlands
-
University of Alabama at BirminghamNot yet recruitingCardiovascular Diseases | Obesity | Insulin Sensitivity/Resistance | Metabolic Disease | Energy Expenditure | MetabolismUnited States
-
Abramson Cancer Center of the University of PennsylvaniaCompleted
-
Nancy Hammond, MDKansas City Area Life Sciences Institute, Inc.CompletedMultiple Sclerosis | Low Bone DensityUnited States
-
Virginia Commonwealth UniversityMassey Cancer CenterCompletedLymphoma | Myelodysplastic Syndromes | Leukemia | Multiple Myeloma | Hodgkin's Lymphoma | Recurrent Hodgkin Lymphoma | Chronic Lymphocytic Leukemia | Non Hodgkin Lymphoma | Acute Lymphocytic Leukemia | Acute Myelogenous Leukemia | Chronic Myelogenous Leukemia | Recurrent Non-Hodgkin Lymphoma | Recurrent Plasma... and other conditionsUnited States