Study of Histological and Adipokines Expression Variations in Lipodystrophic Adipose Tissue During Corticosteroids-induced Lipodystrophy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Expression of adiponectin in adipocytes
研究概览
简要总结
Hypothesis: systemic therapy with corticosteroid induces morphological changes (e.g., moon face, buffalo neck) called lipodystrophy (LD). We hypothesize that this LD is associated with variation of adipocytokines (e.g., adiponectin, leptine, IL6) levels
Primary objective: To show a 50% decrease in adipocytes adiponectin's expression in patients who developed LD versus those who did not developed LD during the first 3 months of a systemic therapy with corticosteroids
Secondary objectives: To look for differences in the mRNA expression of 11bHSD1, SREBP1c and PPARg in fat samples of patients before and after treatment with systemic corticosteroids and between LD+ and LD-patients To compare the fat morphology before and after treatment with glucosteroids
详细描述
Design: Monocentric, cross-sectional analytical study
Subjects: 32 HIV-free and Cushing disease-free adult patients for whom a prolonged treatment (³3months) with glucosteroids (³ 0.5 mg/kg/day) is initiated
Methods: At treatment initiation and 3 months after: comparison of fat sample mRNA expression of adipokines (adiponectin, leptin, IL6, TNFa), 11bHSD1, SREBP1c and PPARg, fat morphology and seric concentrations of adiponectin, leptin, IL6, sTNFR1 between patients LD+ and patients LD-. The diagnosis of LD will be performed by 3 experts using patients photographs
Aims of this study:
- To gain a better understanding of the pathophysiology of glucosteroids-induced LD
- To compare this pathophysiology to the one of HIV-associated LD for which the hypothesis of a local, cellular, hypercorticism has been put forward and for which related treatment have been prescribed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patient
- •starting therapy with prednisone
- •corticosteroid therapy lasting more than 3 months
- •baseline prednisone dosage >= 0.5 mg/kg/d
排除标准
- •Cushing disease
- •HIV +Pregnancy
- •Recent weight lost (> 5% of the usual weight)
- •Therapy with glucocorticosteroids during the past 6 months
结局指标
主要结局
Expression of adiponectin in adipocytes
时间窗: at the inclusion and M3 visits
次要结局
- Plasma levels of adiponectin, leptin, sTNFR1, and IL6(at the inclusion and M3 visits)
- Expression of leptin, IL6, TNFa, 11bHSD1, SREBP1c and PPARg in adipocytes(at the inclusion and M3 visits)
- Histological morphology of adipocytes(at the inclusion and M3 visits)