NCT02145442已完成2 期
Effects and Safety of Obex in Overweight and Obese Subjects With or Without Impaired Fasting Glucose
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- To determine the safety of serious supplement-related adverse events
研究概览
简要总结
- Obesity is an important and growing public health worldwide
- Obesity is highly related to the development of metabolic syndrome, diabetes, cardiovascular diseases and cancer
- An extensive body of evidence from efficacy trials has shown that weight loss is achievable, however, a modest weight loss is achieved in a small proportion of patients
- Important adverse events have been reported with the use of antiobesity drugs.
- The use of natural products with potential effects inducing weight loss is an alternative strategy for treating patients with overweight and obesity. However, efficacy and safety should be evaluated in RCT.
- Obex combines different molecules with potential effects inducing weight loss and control on metabolic parameters such as fasting glucose, cholesterol and triglycerides.
- Therefore, the administration of Obex in overweight and obese patients with impaired fasting glucose could be an excellent strategy to induce weight loss and ameliorate the metabolic disturbances related to obesity and overweight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Overweight and Obese subjects with and without IFG
- •Ability to provide informed consent
排除标准
- •Presence of diabetes mellitus, hepatic, renal or cardiovascular disease
- •Other diseases associated with insulin resistance (eg. Acromegalia, endogenous hypercortisolism, etc)
- •Sepsis or any other condition that could potentially interfere with treatment
- •History of bariatric surgery
- •Pregnancy or lactation
- •Concomitant disease with reduced life expectancy
- •Severe psychiatric conditions
- •Anyone with chronic medical conditions requiring regular intake of any prescription medications.
- •Used drugs for weight loss (e.g., Xenical [orlistat], Meridia [sibutramine], Acutrim [phenylpropanolamine], Accomplia [rimonabant], Alli [low-dose orlistat], or other similar over-the-counter weight loss remedies or medications) within 3 months of screening
- •Are actively participating in, or have participated in a formal weight loss program within the last 3 months
研究组 & 干预措施
Obex
Experimental
Obex®, two oral sachets daily during three months.
干预措施: Obex (Dietary Supplement)
结局指标
主要结局
To determine the safety of serious supplement-related adverse events
时间窗: Three months of treatment
Adverse events will be evaluated during the three months of treatment
To evaluate the effect of Obex® on fasting glucose levels
时间窗: Three months of treatment
The primary outcome is to evaluate the effect of the treatment with Obex® on fasting glucose levels
次要结局
- • To evaluate the effect of Obex® on Body Mass Index (BMI) and Conicity Index (CI)(Three months of treatment)
- To evaluate the effect of Obex® on insulin sensitivity by quantitative insulin sensitivity check index, Bennett and Raynaud insulin sensitivity indexes(Three months of treatment)
- To evaluate the effect of Obex® on the body weight.(Three months of treatment)
- • To evaluate the effect of Obex® on hepatic enzymes (Alanine aminotransferase, Aspartate aminotransferase, gamma-glutamyltransferase, Alkaline Phosphatase)(Three months of treatment)
- To evaluate the effect of Obex® on creatinine and uric acid concentrations(Three months of treatment)
- • To evaluate the effect of Obex® on insulin sensitivity by homeostasis model assessment-estimated insulin resistance (HOMA-IR), calculated from individual serum measures (fasting insulin x fasting glucose/22.5)(Three months of treatment)
- • To evaluate the effect of Obex® on cholesterol, triglyceride and high density lipoprotein cholesterol levels (HDL-c)(Three months of treatment)
- To evaluate the effect of Obex® on Glycosylated Hemoglobin (HbA1c)(Three months of treatment)
- To evaluate the effect of Obex® on the waist and hip circumferences(Three months of treatment)
- To evaluate the effect of Obex® on haemoglobin and serum iron levels(Three months of treatment)
- To evaluate the effect of Obex® on fasting insulin levels(Three months of treatment)
- • To evaluate the effect of Obex® on β-cell function by homeostatic model assessment-beta cell (HOMA-β), calculated from individual serum measures (20 x fasting insulin (µU/mL)/fasting glucose (mmol/L)-3.5)(Three months of treatment)
- To evaluate the effect of Obex® on arterial blood pressures (BP)(Three months of treatment)
研究者
研究点 (2)
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