ObesityNCT02745925
Mechanism of Decreased Iron Absorption in Obesity: Controlling Adiposity-related Inflammation
A study testing Ibuprofen in people with Obesity, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
The main iron regulatory protein in the human metabolism is hepcidin. In normal weight, healthy subjects, hepcidin is regulated through the iron status of the body: low iron status results in low hepcidin concentrations, which facilitates dietary iron absorption. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Ibuprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2016to Dec 2018
- Phase
- Interventional
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- normal-weight (BMI18.5-24.9kg/m2) or obesity (BMI 29-40kg/m2)
- pre-menopausal
- no chronic illness and no significant medical conditions that could influence iron or inflammatory status other than obesity
- no-smoking
Who cannot join
- Diagnosed chronic disease or gastrointestinal disorders
- Metabolic disorders (e.g. diabetes)
- Regular use of medication (except oral contraceptives)
- Subject on a weight loss diet or planning to start a weight loss diet during the duration of the study
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
The main iron regulatory protein in the human metabolism is hepcidin. In normal weight, healthy subjects, hepcidin is regulated through the iron status of the body: low iron status results in low hepcidin concentrations, which facilitates dietary iron absorption. In obesity, which is an inflammatory state, hepcidin concentrations are increased and iron absorption is reduced despite low iron stores, leading to iron deficiency over time. Whether lowering the chronic low-grade inflammation during a limited treatment period and thereby lowering hepcidin concentration can improve iron absorption is uncertain.
Read the detailed description
In states of high hepcidin concentration, intestinal iron absorption (through enterocytes) and recycling of iron (through macrophages) is reduced. The extent to which non-heme iron is absorbed from the diet is influenced by the composition of the diet. Ascorbic acid is a potent enhancer of non-heme iron absorption. It's mechanism of action is luminal reduction of dietary ferric iron (Fe3+) to more soluble ferrous iron (Fe2+). A study in the inestigator's laboratory showed that the enhancing effect of ascorbic acid on non-heme iron absorption is reduced in overweight and obese individuals. Possible explanations for this fact are the different sites of action of ascorbic acid and serum hepcidin on the enterocytes in dietary iron absorption. Increased hepcidin reduces iron efflux into the circulation at the basolateral membrane of the enterocyte. Therefore the improved iron transport into enterocytes through ascorbic acid at the luminal side (via the divalent metal transporter (DMT)-1), by reducing Fe3+ to Fe2+ seems to be less successful. To improve iron absorption in obese subjects, an intervention at the basolateral membrane of the enterocyte would be needed.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
| Study group | Role | What they receive |
|---|---|---|
| normal-weight | Experimental | normal-weight women Receives: Drug: Ibuprofen |
| obesity | Experimental | obese women Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional iron absorption
The fractional iron absorption from four test meals will be calculated based on the shift of the iron isotopic ratios in the collected blood samples 14 days after administration of the isotopically labeled meals. Calculation of fractional iron absorption will take into account the principles of isotope dilution and the fact that iron isotopic labels are not mono-isotopic. The investigators assumed iron incorporation into erythrocytes to be constant. Blood volume, needed for the calculation of fractional iron absorption will be estimated based on available data on blood volume estimations in obese women.
Measured: Days 15 and 45
Secondary outcomes (7)
Plasma ferritin
Measured: Days 1, 15, 30, 45
Hemoglobin
Measured: Days 1, 15, 30, 45
Transferrin receptor
Measured: Days 1, 15, 30, 45
Hepcidin
Measured: Days 1, 15, 30, 45
c-reactive protein
Measured: Days 1, 15, 30, 45
interleukin-6
Measured: Days 1, 15, 30, 45
alpha-1-acid-glycoprotein
Measured: Days 1, 15, 30, 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Monterrey, Mexico
- Responsible party
- Principal investigator, Isabelle Herter-Aeberli, Swiss Federal Institute of Technology
- Investigators
- Isabelle Herter-Aeberli, PhD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745925
- Sponsor's protocol ID
- Fe_Abs_Ibu
- Status last verified
- Oct 2019
- First submitted
- 18 Apr 2016
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Decreased Iron Absorption in Obesity: Controlling Adiposity-related Inflammation
- ClinicalTrials.gov ID
- NCT02745925
- Acronym / sponsor ID
- Fe_Abs_Ibu
- Conditions
- Obesity
- Keywords
- Iron bioavailability, Inflammation, Hepcidin, Iron absorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- University of Monterrey, Mexico
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 20 Apr 2016 (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 main iron regulatory protein in the human metabolism is hepcidin. In normal weight, healthy subjects, hepcidin is regulated through the iron status of the body: low iron status results in low hepcidin concentrations, which facilitates dietary iron absorption. In obesity, which is an inflammatory state, hepcidin concentrations are increased and iron absorption is reduced despite low iron stores, leading to iron deficiency over time. Whether lowering the chronic low-grade inflammation during a limited treatment period and thereby lowering hepcidin concentration can improve iron absorption is uncertain.
Detailed description
In states of high hepcidin concentration, intestinal iron absorption (through enterocytes) and recycling of iron (through macrophages) is reduced. The extent to which non-heme iron is absorbed from the diet is influenced by the composition of the diet. Ascorbic acid is a potent enhancer of non-heme iron absorption. It's mechanism of action is luminal reduction of dietary ferric iron (Fe3+) to more soluble ferrous iron (Fe2+). A study in the inestigator's laboratory showed that the enhancing effect of ascorbic acid on non-heme iron absorption is reduced in overweight and obese individuals. Possible explanations for this fact are the different sites of action of ascorbic acid and serum hepcidin on the enterocytes in dietary iron absorption. Increased hepcidin reduces iron efflux into the circulation at the basolateral membrane of the enterocyte. Therefore the improved iron transport into enterocytes through ascorbic acid at the luminal side (via the divalent metal transporter (DMT)-1), by reducing Fe3+ to Fe2+ seems to be less successful. To improve iron absorption in obese subjects, an intervention at the basolateral membrane of the enterocyte would be needed.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal-weight | Experimental | Drug: Ibuprofennormal-weight women |
| obesity | Experimental | Drug: Ibuprofenobese women |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- normal-weight (BMI18.5-24.9kg/m2) or obesity (BMI 29-40kg/m2)
- pre-menopausal
- no chronic illness and no significant medical conditions that could influence iron or inflammatory status other than obesity
- no-smoking
Key exclusion criteria (5 listed)
- Diagnosed chronic disease or gastrointestinal disorders
- Metabolic disorders (e.g. diabetes)
- Regular use of medication (except oral contraceptives)
- Subject on a weight loss diet or planning to start a weight loss diet during the duration of the study
- Pregnancy or lactation
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 |
|---|---|---|
| Ibuprofen | Drug | normal-weight, obesity |
Primary outcome
Fractional iron absorption
Time frame: Days 15 and 45
The fractional iron absorption from four test meals will be calculated based on the shift of the iron isotopic ratios in the collected blood samples 14 days after administration of the isotopically labeled meals. Calculation of fractional iron absorption will take into account the principles of isotope dilution and the fact that iron isotopic labels are not mono-isotopic. The investigators assumed iron incorporation into erythrocytes to be constant. Blood volume, needed for the calculation of fractional iron absorption will be estimated based on available data on blood volume estimations in obese women.
7 secondary outcomes
Plasma ferritin
Time frame: Days 1, 15, 30, 45
Hemoglobin
Time frame: Days 1, 15, 30, 45
Transferrin receptor
Time frame: Days 1, 15, 30, 45
Hepcidin
Time frame: Days 1, 15, 30, 45
c-reactive protein
Time frame: Days 1, 15, 30, 45
interleukin-6
Time frame: Days 1, 15, 30, 45
alpha-1-acid-glycoprotein
Time frame: Days 1, 15, 30, 45
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 4 Oct 2019.
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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.
Isabelle Herter-Aeberli, PhD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ibuprofen in people with Obesity, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
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 4 inclusion and 5 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 4 Oct 2019. 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 Switzerland. 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 (time frame: Days 15 and 45). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2019.