Evaluation of Baseline and Stimulated GH/IGF-1 AXIS in Obese Subjects in Treatment With Orlistat
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- GH/IGF-1 axis (GH at baseline and after GHRH+Arg; IGF-1, IGFBP3, IGF-1/IGFBP3 ratio)
研究概览
简要总结
The beneficial effects on plasma lipids of Orlistat, a selective gastrointestinal lipase inhibitor, are largely independent of weight loss, and might include differential effects plasma non-esterified fatty acid (NEFA). Apart from their well-known effects on insulin resistance pathogenesis, elevated NEFA levels probably play also the most important role at peripheral levels in the pathogenesis of Growth Hormone (GH) insufficiency in obesity. Aim of this observational, mono-centre, randomized, simple-blind, cross-over study is to verify if the short-term treatment with Orlistat may results in decline in NEFA circulating levels when used in conjunction with low-fat diet and if this effect may restore the endogenous activity of GH/ Insulin-like growth factor (IGF)-1 axis, in the context of GH regulation of lipoprotein metabolism, thus adding a further benefit of Orlistat in obesity cross-linked neuroendocrine and metabolic dearrangement.
详细描述
Subjects:
Twenty obese postmenopausal women (age: 53.6±6.2; BMI: 34.1±4.0. Subjects were recruited, evaluated, and monitored at the Endocrinology Unit of the Department of Molecular and Clinical Endocrinology and Oncology. Before starting the study, all subjects underwent an initial screening assessment including a medical history, physical examination, laboratory parameters, and body weight.
Treatment protocol:
At study entry plasma samples were obtained for fasting plasma glucose, insulin, lipaemia (total, HDL and LDL cholesterol, tryglycerides), GH, IGF-1, and IGFBP-3. The subjects were randomized in two groups of treatment: 10 subjects received normo-caloric diet plus + orlistat (Xenical, Roche, UK) at a dose of 120 mg tid; 10 subjects received normo-caloric diet without the additional treatment. The duration of follow-up was 10 days for each treatment period, without any wash-out between the two periods. Each patient has been assigned to each group. Dynamic testing performed at the end of each period were the following: glucose, and insulin after an OGTT; GH after GHRH + arginine (GHRH+ARG); post-prandial lipaemia after a standard fat-rich meal. During the study period, the subjects maintained their usual pattern of physical activity. Subjects and investigators remained unaware of laboratory results until the end of the study.
Methods
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •post-menopausal age
- •class I-II obesity
- •normal thyroid, liver, and kidney function
排除标准
- •type 2 diabetes mellitus
- •use of hypolipaemic agents
研究组 & 干预措施
orlistat plus normo-caloric diet
10 subjects received normo-caloric diet plus + orlistat (Xenical, Roche, UK) at a dose of 120 mg tid. The duration of follow-up was 10 days
干预措施: Orlistat (Drug)
orlistat plus normo-caloric diet
10 subjects received normo-caloric diet plus + orlistat (Xenical, Roche, UK) at a dose of 120 mg tid. The duration of follow-up was 10 days
干预措施: normo-caloric diet (Other)
normo-caloric diet
10 subjects received normo-caloric diet without the additional treatment. The duration of follow-up was 10 days
干预措施: normo-caloric diet (Other)
结局指标
主要结局
GH/IGF-1 axis (GH at baseline and after GHRH+Arg; IGF-1, IGFBP3, IGF-1/IGFBP3 ratio)
时间窗: 20 days
次要结局
- glucose metabolism: OGTT, Insulin resistance (HOMA-R - homeostasis model assessment of insulin resistance) index, Insulin Sensitivity Index (ISI)(20 days)
- fasting lipaemia (total, HDL and LDL cholesterol, tryglycerides, NEFA, total/HDL cholesterol ratio(20 days)
- post-prandial lipaemia (total, HDL and LDL cholesterol, tryglycerides, NEFA)(20 days)
- Antropometric indexes: Body mass index (BMI), waist circumference(20 days)