跳至主要内容
临床试验/NCT00387114
NCT00387114终止3 期

Effect of an Anti-Oxidant Treatment on Resistin Serum Levels.A Randomized Study

University of Turin, Italy2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2005年6月1日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
终止
发起方
入组人数
80
试验地点
2
主要终点
Mean resistin serum level reduction, after vitamin C treatment, of at least 0.50 standardized units.

研究概览

简要总结

The aim of the present study was to evaluate whether an in vivo treatment with an antioxidant vitamin (vitamin C) might substantially affect serum levels of resistin, a recently described adipokine, whose clinical significance is still controversial in humans.

详细描述

INTRODUCTION

Background

Resistin, a recently described adipokine, belonging to the cysteine-rich secretory protein family, was originally described as an adipocyte-derived polypeptide, that provides the link between obesity and insulin resistance in mice1-2. However, resistin is expressed at very low concentrations in human adipose cells, whereas at high levels in mononuclear leukocytes, macrophages, spleen, bone marrow cells. The striking differences in the genomic organization and cellular source of resistin in rodents make the biological effects found in the mouse not readily transferable to humans3-5. Accordingly, an increasing number of reports raised doubts regarding the possibility of an important relationship between human resistin and various metabolic disturbances, characteristic of obesity and type 2 diabetes4-5. Resistin was originally found to be related to proteins induced during lung inflammation6, and the high expression levels of resistin in leukocytes, the associations between this protein and inflammatory markers, the property to stimulate in vivo inflammatory cytokines suggest the possibility that resistin may be involved in the inflammation process6.

Data supporting the participation of resistin in oxidative processes have been sporadically published. A significant interaction among a single nucleotide polymorphism in the promoter of the human resistin gene and a marker of oxidative stress (NAD(P)H:quinone oxidoreductase I) has been found7. Retinoic acid, the acid form of vitamin A, inhibited the expression of resistin in mice and reduced the higher resistin levels of ten males affected by psoriasis8. Resistin serum levels were inversely associated with nitrotyrosine (NT), a product of free radical activity9.

A pilot-analysis performed in five healthy volunteers showed that oral administration of vitamin C for 15 days determined a slight reduction in resistin serum levels.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age 20-50 years
  • absence of known hyperglycemia, hypertension, cardiovascular disease, impaired renal function, liver disease, or any other systemic conditions no use of any drug, estrogen included
  • not being on a particular diet and/or vitamin or other nutrient supplementation

排除标准

  • actual pregnancy
  • known hyperglycemia, hypertension, cardiovascular disease, impaired renal function, liver disease, or any other systemic conditions
  • use of any drug, estrogen included
  • being on a particular diet, vitamin or other nutrient supplementation
  • history of renal calculi.

结局指标

主要结局

Mean resistin serum level reduction, after vitamin C treatment, of at least 0.50 standardized units.

次要结局

  • The within- and between-group variations in the other inflammatory and oxidative variables measured.

研究者

发起方
University of Turin, Italy
申办方类型
Other

研究点 (2)

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