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Hepcidin Behavior in Patients With Obesity and Bariatric Surgery

Hepcidin Behavior in Patients With Obesity and Bariatric Surgery

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03990948
Acronym
HOBS
Enrollment
300
Registered
2019-06-19
Start date
2019-01-08
Completion date
2023-12-12
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepcidin

Brief 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. 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.

Interventions

OTHERBlood sampling

Blood sample collection

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Serum hepcidin concentrationStudy visit 1 daySerum hepcidin concentration

Secondary

MeasureTime frameDescription
Mean corpuscular volumeStudy visit 1 dayMean corpuscular volume
Iron concentrationStudy visit 1 dayIron concentration
Ferritin concentrationStudy visit 1 dayFerritin concentration
Transferrin concentrationStudy visit 1 dayTransferrin concentration
Hemoglobin concentrationStudy visit 1 dayHemoglobin concentration
C-reactive proteinStudy visit 1 dayC-reactive protein
Vitamin B12 concentrationStudy visit 1 dayVitamin B12 concentration
Folate (RBC level)Study visit 1 dayFolate (RBC level)
Folate (serum level)Study visit 1 dayFolate (serum level)
Transferrin saturationStudy visit 1 dayTransferrin saturation

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026