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临床试验/NCT01347905
NCT01347905
已完成
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Changes in Iron Absorption and Availability Before and After Weight Loss in Obese Pre-menopausal Women and Men.

Wageningen University1 个研究点 分布在 1 个国家目标入组 43 人2011年2月
适应症Obesity

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Obesity
发起方
Wageningen University
入组人数
43
试验地点
1
主要终点
Fractional iron absorption before and after weight loss, based on 57Fe and 58Fe isotope concentrations in erythrocytes.
状态
已完成
最后更新
10年前

概览

简要总结

The objective of this study is to investigate if weight loss, in particular due to adipose tissue loss, in obese patients will reverse the obesity-related reduction of iron absorption, and if this is due to a decrease in hepcidin concentrations. Additionally, the investigators will investigate changes in iron incorporation into erythrocytes due to a reduction of iron sequestration by the adipose tissue and reticuloendothelial system. The investigators expect that by decreasing adiposity, circulating hepcidin levels will decrease, iron absorption and incorporation into erythrocytes will increase and as a result iron status will be improved.

详细描述

Until now adiposity has been associated with low iron status and with higher hepcidin levels. Moreover, weight loss and thereby loss of fat mass, has been associated with decreased hepcidin levels and improved iron status. However, until now no direct measures of iron absorption or incorporation into erythrocytes have been assessed before and after losing weight/fat mass. We hypothesize that: * body fat loss in obese women and men will improve iron absorption, corrected for iron status, from a labeled test meal measured by using a stable isotopes technique by on average 30%. * body fat loss in obese women and men will decrease the related inflammatory state. * greater subclinical inflammation in obese women and men will be correlated with a decreased incorporation of iron into erythrocytes, and that this will improve after loss of body fat. The study is a prospective cohort in which iron bioavailability will be assessed in obese women and men before and after weight loss and associated loss of body fat over a period of 6 months. Iron absorption will be estimated using stable-isotope techniques where incorporation of 57Fe and 58Fe into erythrocytes is measured 14 days after administration. Preparation of isotopically labelled iron will be done at the Laboratory of Human Nutrition of the Swiss Federal Institute of Technology Zurich (ETH Zürich). A baseline venous blood sample will be drawn 6-8 weeks after the surgery when surgery-related inflammation has been resolved. The subjects will receive a test drink, containing 6 mg of 57Fe labelled ferrous sulphate. One hour later, 2 ml of an aqueous solution containing 100 μg 58Fe as iron citrate in 250 cc of normal saline will be infused over 50 min. This infusion protocol has been used safely and successfully to examine iron metabolism in both adults and infants. Fourteen days later, a second venous blood sample will be drawn. This procedure will be performed at baseline (6-8 weeks post-surgery) and at the end of the study (6 months post baseline). Our study could provide important information to establish the mechanism by which obesity-mediated inflammation could induce iron deficiency. This will be the first human trial that will evaluate if the obesity-related reduction of iron absorption is reversible in a context where obesity and iron deficiency are both highly prevalent.

注册库
clinicaltrials.gov
开始日期
2011年2月
结束日期
2013年12月
最后更新
10年前
研究类型
Observational
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Women and men
  • aged 18 to 50 years
  • Premenopausal (had no absence of menstrual cycle in the past 12 months)
  • BMI ≥35\<45
  • Indication for laparoscopic Sleeve Gastrectomy (LSG) or Laparoscopic Adjustable Gastric Band (LAGB).
  • Subjects are eligible for this surgery if they:
  • have BMI ≥35\<45 and one of the following two conditions:
  • Medical, physical or psychosocial problems associated with their obesity.
  • A history of prolonged attempts at weight loss by other means.
  • have been adequately informed and understood and accepted the potential -- risks and benefits of the procedure, and expressed a commitment to follow the rules regarding eating and exercise permanently after the procedure.

排除标准

  • Reported excessive blood loss at surgery (\> 500 ml) and/or moderate/severe anemic (Hb \< 100 g/L)
  • Complications during restrictive bariatric surgery defined as either:
  • Surgery duration of \> 3 hours
  • Blood loss of \> 500 ml
  • Perforation of the gastrointestinal tract
  • Inability to adjust lapband
  • Women and men with diagnosed abnormalities in iron metabolism (diagnosed from routine pre-surgery blood sample)

结局指标

主要结局

Fractional iron absorption before and after weight loss, based on 57Fe and 58Fe isotope concentrations in erythrocytes.

时间窗: 6 months

次要结局

  • Iron status and regulatory markers (Hb, serum ferritin, transferrin receptor, hepcidin),(pro)inflammatory markers (CRP, AGP, TNF-α, IL-6, leptin), blood volume, body composition (DXA).(6 months)

研究点 (1)

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