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Adipose Tissue & Uremia (MODAIR)

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Chronic Kidney Disease - Stage V

Treatments

Other: Biopsy of abdominal subcutaneous white adipose tissue (2-3 g)

Study type

Interventional

Funder types

Other

Identifiers

NCT02902705
2008.520

Details and patient eligibility

About

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).

Enrollment

23 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

23 participants in 2 patient groups

Chronic Kidney disease patients - stage V
Experimental group
Description:
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).
Treatment:
Other: Biopsy of abdominal subcutaneous white adipose tissue (2-3 g)
Non Chronic Kidney Disease patients
Other group
Description:
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).
Treatment:
Other: Biopsy of abdominal subcutaneous white adipose tissue (2-3 g)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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