ObesityNCT01347905
Changes in Iron Absorption and Availability Before and After Weight Loss in Obese Pre-menopausal Women and Men.
An observational study of Obesity, run by Wageningen University at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Obesity
- What is being tested?
- Stable-isotope techniques
- Type of treatment
- Injection or infusion
- How many people
- 43 participants
- Where
- 1 siteMexico
- Study dates
- Feb 2011to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Obese, premenopausal women and men aged 18 to 50 years after having undergone restrictive bariatric surgery.
Who may be able to join
- 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:
Show all 24Show fewer
- 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.
- Non-lactating in the 6 weeks prior to the study and for the duration of the study
- No reported weight loss ≥ 10 % of bodyweight during a period of six months before pre-surgery examination.
- No full or partial hysterectomy in the past 3 months
- Informed consent signed
- Agreeing to be informed about medically relevant personal test-results by a physician.
- Agreeing to be informed about medically relevant personal test-results by a physician.
- No reported participation in night shift work two weeks prior to pre-study investigation and during the study. Night work is defined as working between midnight and 6.00 AM.
- Consumption of =< 14 alcoholic drinks in a typical week
- Strenuous exercise =< 10 hours per week
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Universidad de Monterrey (UDEM) División de Ciencias de la Salud
San Pedro Garza García, Nuevo León, 66238
About this study
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.
Read the detailed description
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.
- Conditions
- Obesity
- Being tested
- Stable-isotope techniques
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stable-isotope techniquesOther
Also called 57Fe ferrous sulphate, 58Fe iron citrate
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Stable-isotope techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional iron absorption before and after weight loss, based on 57Fe and 58Fe isotope concentrations in erythrocytes.
Measured: 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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startFeb 2011
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Monterrey, Mexican National Institute of Public Health, Swiss Federal Institute of Technology, Unilever R&D
- Responsible party
- Sponsor
- Investigators
- Michael B Zimmermann, MD PHD, Study director, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347905
- Sponsor's protocol ID
- Iron absorption and obesity
- Status last verified
- Jun 2015
- First submitted
- 3 May 2011
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27557657
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Iron Absorption and Availability Before and After Weight Loss in Obese Pre-menopausal Women and Men.
- ClinicalTrials.gov ID
- NCT01347905
- Acronym / sponsor ID
- Iron absorption and obesity
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Universidad de Monterrey, Mexican National Institute of Public Health, Swiss Federal Institute of Technology, Unilever R&D
- Study start
- Feb 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese women and men | – | Other: Stable-isotope techniquesObese 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). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Obese, premenopausal women and men aged 18 to 50 years after having undergone restrictive bariatric surgery.
Key inclusion criteria (24 listed)
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stable-isotope techniquesAlso: 57Fe ferrous sulphate, 58Fe iron citrateIron 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). | Other | Obese women and men |
Primary outcome
Fractional iron absorption before and after weight loss, based on 57Fe and 58Fe isotope concentrations in erythrocytes.
Time frame: 6 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
- Derived from this study: PubMed 27557657Cepeda-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.
- Does obesity increase risk for iron deficiency? A review of the literature and the potential mechanisms.Link provided by the sponsor.
- 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.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael B Zimmermann, MD PHD study director
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Wageningen University at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional iron absorption before and after weight loss, based on 57Fe and 58Fe isotope concentrations in erythrocytes. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01347905, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2015.