Changes in Iron Absorption and Availability Before and After Weight Loss in Obese Pre-menopausal Women and Men.
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Changes in Iron Absorption and Availability Before and After Weight Loss in Obese Pre-menopausal Women and Men.|
- Fractional iron absorption before and after weight loss, based on 57Fe and 58Fe isotope concentrations in erythrocytes. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
whole blood and serum
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||November 2012|
|Estimated Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Obese women and men
Obese women and men undergoing restrictive bariatric surgery
Other: Stable-isotope techniques
Iron absorption will be estimated using stable-isotope techniques where incorporation of 57Fe and 58Fe into erythrocytes is measured 14 days after administration. The subjects will provide an initial blood sample (20ml) and then receive a test drink, containing 6 mg of 57Fe labeled ferrous sulphate. One hour later, 2 ml of an aqueous solution containing 100 μg 58Fe, as iron citrate in 250cc of normal saline will be infused over 50 min. Post infusion a 4ml blood sample will be taken. This procedure will be performed at baseline (6 weeks post-surgery) and at the end of the study (6-7 months post baseline).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01347905
|Contact: Rogelio D Cervantes Madrid, MD PHD||5281821000 ext firstname.lastname@example.org|
|Contact: Ana C Cepeda-Lopez, MD MNH||5281821000 ext email@example.com|
|Universidad de Monterrey (UDEM) División de Ciencias de la Salud||Recruiting|
|San Pedro Garza García, Nuevo Leon, Mexico, 66238|
|Contact: Ana C Cepeda-Lopez, MD MNH 52811000 ext 1265 firstname.lastname@example.org|
|Sub-Investigator: Ana C Cepeda-Lopez, MD MNH|
|Principal Investigator: Rogelio D Cervantes-Madrid, MD PHD|
|Study Director:||Michael B Zimmermann, MD PHD||Wageningen University|