HepcidinHOBSNCT03990948
Hepcidin Behavior in Patients With Obesity and Bariatric Surgery
An observational study of Hepcidin, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Iron deficiency is one of the most common nutritional problems observed in patients with obesity and after bariatric surgery. From a therapeutic point of view, iron deficiency can lead to iron deficiency anemia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepcidin
- What is being tested?
- Blood sampling
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Jan 2019to 12 Dec 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with obesity, patients with a Sleeve Gasterctomy or patients with a Roux-en-Y Gastric Bypass
Who may be able to join
- The patient has to be 18 years or older
- Written informed consent has to be obtained after being informed on all aspects of the study
- The patient has a BMI > 30 kg/m² OR There has to be at least one year between the primary RYGB and the participation in the study OR There has to be at least one year between the primary SG and the participation in the study
Who cannot join
- Patients younger than 18 years old
- Women who are pregnant or are breastfeeding
- Post-menopausal women, defined as at least 6 months of amenorrhea after the final menstrual period
- Inability to follow the procedures of the studies due to language problems
- Patients who have had more than one bariatric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Iron deficiency is one of the most common nutritional problems observed in patients with obesity and after bariatric surgery. From a therapeutic point of view, iron deficiency can lead to iron deficiency anemia. Iron supplementation carries the risk of exacerbating infections, altering the gut microbiome and iron overload. Therefore, it would be beneficial to use iron supplementation only in truly iron deficient patients. To date, different studies have observed that hepcidin could be a possible indicator of iron status and absorption in different patient populations. Furthermore, it could be used to distinguish anemia due to iron deficiency from inflammation and globin disorder related anemia. How hepcidin concentrations variate in patients with obesity and after bariatric surgery remains unsure.
Read the detailed description
During the visit in the obesity clinic, eligible patients will be approached for participation by the sub-investigator. Interested patients will receive information regarding the study and receive the information sheet containing the informed consent form. After signing the informed consent form, general information will be collected regarding medical and demographic data using a short questionnaire. Additional questionnaires regarding demographics and menstrual cycle will be collected. Anthropometric measurements will be collected for the determination of the length, weight, hip circumference, waist circumference and body composition. Finally, blood samples will be collected for the determination of iron and inflammation related markers.
- Conditions
- Hepcidin
- Being tested
- Blood sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Blood sample collection
| Study group | Role | What they receive |
|---|---|---|
| Patients with obesity | In 100 patients with obesity, blood samples will be collected. Receives: Other: Blood sampling | |
| Patients with a Sleeve Gastrectomy | In 100 patients with a Sleeve Gastrectomy, blood samples will be collected. Receives: Other: Blood sampling | |
| Patients with a Roux-en-Y Gastric Bypass | In 100 patients with a Roux-en-Y Gastric Bypass, blood samples will be collected. Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum hepcidin concentration
Serum hepcidin concentration
Measured: Study visit 1 day
Secondary outcomes (10)
Hemoglobin concentration
Hemoglobin concentration
Measured: Study visit 1 day
Mean corpuscular volume
Mean corpuscular volume
Measured: Study visit 1 day
Iron concentration
Iron concentration
Measured: Study visit 1 day
Ferritin concentration
Ferritin concentration
Measured: Study visit 1 day
Transferrin concentration
Transferrin concentration
Measured: Study visit 1 day
Transferrin saturation
Transferrin saturation
Measured: Study visit 1 day
C-reactive protein
C-reactive protein
Measured: Study visit 1 day
Vitamin B12 concentration
Vitamin B12 concentration
Measured: Study visit 1 day
Folate (RBC level)
Folate (RBC level)
Measured: Study visit 1 day
Folate (serum level)
Folate (serum level)
Measured: Study visit 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start8 Jan 2019
- Primary completion12 Dec 2023
- Study completion12 Dec 2023
Why it stopped: Terminated early
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepcidinStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990948
- Sponsor's protocol ID
- S62085
- Acronym
- HOBS
- Status last verified
- Oct 2022
- First submitted
- 17 Jun 2019
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepcidin Behavior in Patients With Obesity and Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03990948
- Acronym / sponsor ID
- HOBS / S62085
- Conditions
- Hepcidin
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated early
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 19 Jun 2019 (actual)
- 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.
Iron deficiency is one of the most common nutritional problems observed in patients with obesity and after bariatric surgery. From a therapeutic point of view, iron deficiency can lead to iron deficiency anemia. Iron supplementation carries the risk of exacerbating infections, altering the gut microbiome and iron overload. Therefore, it would be beneficial to use iron supplementation only in truly iron deficient patients. To date, different studies have observed that hepcidin could be a possible indicator of iron status and absorption in different patient populations. Furthermore, it could be used to distinguish anemia due to iron deficiency from inflammation and globin disorder related anemia. How hepcidin concentrations variate in patients with obesity and after bariatric surgery remains unsure.
Detailed description
During the visit in the obesity clinic, eligible patients will be approached for participation by the sub-investigator. Interested patients will receive information regarding the study and receive the information sheet containing the informed consent form. After signing the informed consent form, general information will be collected regarding medical and demographic data using a short questionnaire. Additional questionnaires regarding demographics and menstrual cycle will be collected. Anthropometric measurements will be collected for the determination of the length, weight, hip circumference, waist circumference and body composition. Finally, blood samples will be collected for the determination of iron and inflammation related markers.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with obesity | – | Other: Blood samplingIn 100 patients with obesity, blood samples will be collected. |
| Patients with a Sleeve Gastrectomy | – | Other: Blood samplingIn 100 patients with a Sleeve Gastrectomy, blood samples will be collected. |
| Patients with a Roux-en-Y Gastric Bypass | – | Other: Blood samplingIn 100 patients with a Roux-en-Y Gastric Bypass, blood samples will be collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with obesity, patients with a Sleeve Gasterctomy or patients with a Roux-en-Y Gastric Bypass
Key inclusion criteria (3 listed)
- The patient has to be 18 years or older
- Written informed consent has to be obtained after being informed on all aspects of the study
- The patient has a BMI > 30 kg/m² OR There has to be at least one year between the primary RYGB and the participation in the study OR There has to be at least one year between the primary SG and the participation in the study
Key exclusion criteria (5 listed)
- Patients younger than 18 years old
- Women who are pregnant or are breastfeeding
- Post-menopausal women, defined as at least 6 months of amenorrhea after the final menstrual period
- Inability to follow the procedures of the studies due to language problems
- Patients who have had more than one bariatric surgery
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 |
|---|---|---|
| Blood samplingBlood sample collection | Other | Patients with a Roux-en-Y Gastric Bypass, Patients with a Sleeve Gastrectomy, Patients with obesity |
Primary outcome
Serum hepcidin concentration
Time frame: Study visit 1 day
Serum hepcidin concentration
10 secondary outcomes
Hemoglobin concentration
Time frame: Study visit 1 day
Mean corpuscular volume
Time frame: Study visit 1 day
Iron concentration
Time frame: Study visit 1 day
Ferritin concentration
Time frame: Study visit 1 day
Transferrin concentration
Time frame: Study visit 1 day
Transferrin saturation
Time frame: Study visit 1 day
C-reactive protein
Time frame: Study visit 1 day
Vitamin B12 concentration
Time frame: Study visit 1 day
Folate (RBC level)
Time frame: Study visit 1 day
Folate (serum level)
Time frame: Study visit 1 day
Results and safety
The study was stopped early (reason given: Terminated early). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hepcidin, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 3 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: stopped early, as of the sponsor's last update on 3 Jul 2024. 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 Belgium. 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 was stopped early (reason given: Terminated early). Results are not available in the source record.
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?
Serum hepcidin concentration (time frame: Study visit 1 day). 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 3 Jul 2024.