Morphological and Functional Changes in White Adipose Tissue in Nondiabetic Chronic Kidney Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Mean adipocyte size (in µm) in subcutaneous white adipose tissue removed during biopsy, measured with a Beckman Coulter
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Mean adipocyte size (in µm) in subcutaneous white adipose tissue removed during biopsy, measured with a Beckman Coulter
时间窗: 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.
次要结局
未报告次要终点