Clinical trial NCT02902705: Adipose Tissue & Uremia
Official title: Morphological and Functional Changes in White Adipose Tissue in Nondiabetic Chronic Kidney Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease - Stage V
Keywords: White adipose tissue
chronic kidney disease
uremia
adipocytes
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 23
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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. 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).


Eligibility criteria: 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

Primary outcomes:
measure: Mean adipocyte size (in µm) in subcutaneous white adipose tissue removed during biopsy, measured with a Beckman Coulter
timeFrame: Day 1, the day of surgery (one day after inclusion)
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de Néphrologie, dialyse, hypertension artérielle - Pavillon P - Hôpital Edouard Herriot -
Study officials:
References: