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钨酸钠治疗人类肥胖的概念验证试验。

Proof-of-concept trial on the efficacy of sodium tungstate in human obesity.

机构信息

Endocrinology and Nutrition Department, Hospital Clínic, IDIBAPS, Barcelona University, Barcelona, Spain.

出版信息

Diabetes Obes Metab. 2010 Nov;12(11):1013-8. doi: 10.1111/j.1463-1326.2010.01293.x.

DOI:10.1111/j.1463-1326.2010.01293.x
PMID:20880348
Abstract

AIM

Considering the poor long-term success of current dietary and pharmacological interventions, we aimed to evaluate the potential effect of sodium tungstate in the treatment of grade I and II obesity (ClinicalTrials.gov identifier: NCT00555074).

METHODS

Prospective, randomized, placebo-controlled, double-blind, proof-of-concept study was carried out. Following a 2-week lead-in period, 30 obese (body mass index, BMI 30.0-39.9 kg/m(2)), non-diabetic subjects were randomized to receive either sodium tungstate (100 mg bid) or placebo for 6 weeks. The primary study endpoint was the absolute change in body weight relative to the time of randomization.

RESULTS

Treatment with sodium tungstate [-0.135 ± 0.268 kg (95% CI -0.686 to +0.416 kg)] was not associated with a significant weight loss compared to placebo [-0.063 ± 0.277 kg (95% CI -0.632 to +0.507 kg)] (p = 0.854). Likewise, treatment with sodium tungstate was not associated with significant changes in fat mass (DEXA), resting energy expenditure (indirect calorimetry) or caloric consumption (3-day food records).

CONCLUSION

Our data do not support sodium tungstate as a pharmacological agent in the treatment of human obesity.

摘要

目的

鉴于目前饮食和药物干预的长期效果不佳,我们旨在评估偏钨酸钠治疗 I 级和 II 级肥胖的潜在疗效(临床试验.gov 标识符:NCT00555074)。

方法

进行了一项前瞻性、随机、安慰剂对照、双盲、概念验证研究。在为期 2 周的导入期后,将 30 名肥胖(体重指数,BMI 30.0-39.9kg/m²)、非糖尿病受试者随机分为两组,分别接受偏钨酸钠(100mg,每日 2 次)或安慰剂治疗 6 周。主要研究终点是与随机分组时间相比体重的绝对变化。

结果

与安慰剂组(-0.063±0.277kg,95%置信区间-0.632 至+0.507kg)相比,偏钨酸钠治疗组(-0.135±0.268kg,95%置信区间-0.686 至+0.416kg)的体重减轻并不显著(p=0.854)。同样,偏钨酸钠治疗与脂肪量(DEXA)、静息能量消耗(间接热量法)或热量摄入(3 天食物记录)的显著变化无关。

结论

我们的数据不支持偏钨酸钠作为治疗人类肥胖的药物。

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