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临床试验/NCT01842425
NCT01842425Unknown不适用

Changes in Body- and Liver-composition During Low Calorie Diet in Morbidly Obese

Uppsala University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Liver volume

研究概览

简要总结

The purpose of this study is to determine what changes occur in body- and liver-composition during four weeks of low calorie diet in morbidly obese females

详细描述

Preoperative weight loss prior to laparoscopic gastric bypass is desirable as this reduces liver volume and thus facilitates the visualization of the gastro-esophageal junction. Weight loss is often achieved through low-calorie diet (LCD); however the ideal duration of LCD treatment is unknown.

Morbidly obese female patients awaiting laparoscopic gastric bypass are recruited. They are, as all our patients, treated during four weeks with LCD to achieve a decrease in liver size. During this period they are examined on day 0, 3, 7, 14 and 28 after commencing LCD.

At each evaluation, body composition is assessed through bioelectric impedance analysis (BIA), liver volume and intrahepatic fat through magnetic resonance imaging. A questionnaire regarding quality of life and LCD-related symptoms is administered as well. At surgery two samples of subcutaneous fat and one sample of omental fat is taken.

We do not assign patients to different treatments, instead all are treated similarly according to our routine preoperative regimen.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Awaiting laparoscopic gastric bypass
  • Residing near Uppsala

排除标准

  • Weight above 140 kg
  • Metal implants such as pacemaker or intracerebral clips
  • Failure to understand or comply with study protocol

结局指标

主要结局

Liver volume

时间窗: From baseline to after four weeks

次要结局

  • Changes in body composition(Baseline to 4 weeks)
  • Composition of body fat in subcutaneous and omental fat(At surgery)

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Principal Investigator
主要研究者

DEdholm

MD

Uppsala University

研究点 (1)

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