Changes in Iron Absorption and Availability Before and After Weight Loss in Obese Pre-menopausal Women and Men.

NCT01347905 | Completed DMC

• 1 other identifier: Iron absorption and obesity
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (1)

• 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

Study Arms (1)

Obese women and men

Obese women and men undergoing restrictive bariatric surgery. Iron absorption will be estimated using stable-isotope techniques where incorporation of 57Fe and 58Fe into erythrocytes is measured 14 days after administration. This procedure will be performed at baseline (6 weeks post-surgery) and at the end of the study (6-7 months post baseline).

Other: Stable-isotope techniques

Interventions

Stable-isotope techniques OTHER

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).

Also known as: 57Fe ferrous sulphate, 58Fe iron citrate

Obese women and men

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Obese, premenopausal women and men aged 18 to 50 years after having undergone restrictive bariatric surgery.

You may qualify if:

• 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.
• No postoperative complications after the surgery
• Apparently healthy: no significant medical conditions that could influence iron or inflammatory status other than obesity (i.e., cancer, HIV/AIDS, inflammatory bowel disease, gastrointestinal bleeding, and rheumatoid arthritis, renal disease or hemochromatosis) (judged by study physician).
• No use of medication which interferes with study measurements (as judged by the study physician)
• Willing to not change their intake of dietary iron and not take additional iron supplements, other than provided by the study team, between baseline and study end.
• Not being pregnant during the study period or in the six months prior to the study and not planning to become pregnant until at least 3 months after the last study visit.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wageningen University: lead
• Universidad de Monterrey: collaborator
• Mexican National Institute of Public Health: collaborator
• Swiss Federal Institute of Technology: collaborator
• Unilever R&D: collaborator

Study Sites (1)

Universidad de Monterrey (UDEM) División de Ciencias de la Salud

San Pedro Garza García, Nuevo León, 66238, Mexico

Location

Related Publications (1)

• Cepeda-Lopez AC, Allende-Labastida J, Melse-Boonstra A, Osendarp SJ, Herter-Aeberli I, Moretti D, Rodriguez-Lastra R, Gonzalez-Salazar F, Villalpando S, Zimmermann MB. The effects of fat loss after bariatric surgery on inflammation, serum hepcidin, and iron absorption: a prospective 6-mo iron stable isotope study. Am J Clin Nutr. 2016 Oct;104(4):1030-1038. doi: 10.3945/ajcn.115.115592. Epub 2016 Aug 24.

  PMID: 27557657 DERIVED

Related Links

• Does obesity increase risk for iron deficiency? A review of the literature and the potential mechanisms.
• Sharply higher rates of iron deficiency in obese Mexican women and children are predicted by obesity-related inflammation rather than by differences in dietary iron intake.

Biospecimen

Retention: SAMPLES WITH DNA

whole blood and serum

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael B Zimmermann, MD PHD

  Wageningen University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2011
• First Posted: May 5, 2011
• Study Start: February 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 9, 2015

Record last verified: 2015-06

Locations

ME (1)