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临床试验/NCT01692327
NCT01692327已完成不适用

Evaluating the Effect of Lipid Overload in Endothelial Function and Microvascular Reactivity in Young Obese Women

Rio de Janeiro State University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Microvascular function

研究概览

简要总结

The hypothesis of the proposed project is that after a fat overload, the postprandial response is different in both groups, suggesting that the LPP will present the most significant damage in endothelial vasomotion in obese individuals, especially those with GI and T2DM. After the fat overload, we hypothesized that there will be a worsening of endothelial function and microvascular reactivity in OB/DM2 and OB group compared to C, but also find lower concentrations of incretins in OB/DM2 group compared to other groups.

These hypotheses may be confirmed by techniques for evaluating microvascular function, the use of DFT skin for vasomotion evaluation and finally analysis of analytes through metabolic and cardiovascular read by Multiplex kit.

详细描述

Will be recruited 60 women aged 19-40 years, with a diagnosis of obesity (BMI ≥ 30 kg/m2) treated at the obesity clinic at the State University of Rio de Janeiro (UERJ)at Brazil.

Microcirculation parameters and blood tests will be assessed at baseline and after this, the women will receive a high-fat meal containing croissant, salami, whole milk and cheddar cheese. After 30, 60, 120 and 180 minutes this meal the microcirculation will be evaluated as well as blood collection.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Investigator)

入排标准

年龄范围
19 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • all patients should have obesity class I (BMI between 30 and 35kg/m2);
  • Submit diabetes mellitus without further treatment or be obese non-diabetic or glucose intolerant;
  • Presenting the age between 19 to 40 years.
  • Waist circumference> 80 cm (IDF)

排除标准

  • Renal disease, coronary or peripheral vascular, hematologic or hepatic impairment;
  • Presence of dyslipidemia;
  • Significant loss of body weight six months prior to the study.

结局指标

主要结局

Microvascular function

时间窗: up to 180 minutes after high fat meal

次要结局

  • incretins hormones(basal, 30, 60, 120,180 minutes after high fat meal)

研究者

发起方
Rio de Janeiro State University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Priscila Alves Maranhao

Nutricionist

Rio de Janeiro State University

研究点 (2)

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