NCT00555074已完成2 期
Efficacy of Oral Sodium Tungstate (200 mg/Day)on Weight Loss in Subjects With Grade I-II Obesity
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- weight loss
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of sodium tungstate versus placebo in patients with obesity (grade I and II).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI: 30-39.9 Kg/m2
- •In case of male gender, 18 to 65 years old
- •In case of female gender, diagnosis of menopause
- •Body weight changes < 3 kg in the last 3 months
- •In case of arterial hypertension or dyslipemia, no changes in dose in the last 2 months
- •Exclusion criteria:
- •In case of female gender, absence of menopause
- •Evidence of secondary causes of obesity
- •Diabetes, type II
- •Concomitant treatment with drugs affecting body weight
- •Previous surgical intervention of obesity
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
Sodium Tungstate
干预措施: Sodium Tungstate (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
weight loss
时间窗: six weeks
次要结局
- changes in lipids(6 weeks)
- changes in caloric intake and in hungry sensation(6 weeks)
- resting metabolic rate(6 weeks)
- changes in body composition(6 weeks)
- adverse events(6 weeks)
- changes in hormonal parameters(6 weeks)
研究者
研究点 (1)
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