Hepcidin Behavior in Patients With Obesity and Bariatric Surgery

Hepcidin Clinical Trial

— HOBS  

Official title:

Hepcidin Behavior in Patients With Obesity and Bariatric Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03990948
• Other study ID #: S62085
• Status: Recruiting
• Start date: January 8, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2022
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Nele Steenackers, MSc
• Phone: 0032 016 34 49 13
• Email: nele.steenackers[@]kuleuven.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepcidin
• Obesity

Intervention

Other:
• Blood sampling
Blood sample collection

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum hepcidin concentration	Serum hepcidin concentration	Study visit 1 day
Secondary	Hemoglobin concentration	Hemoglobin concentration	Study visit 1 day
Secondary	Mean corpuscular volume	Mean corpuscular volume	Study visit 1 day
Secondary	Iron concentration	Iron concentration	Study visit 1 day
Secondary	Ferritin concentration	Ferritin concentration	Study visit 1 day
Secondary	Transferrin concentration	Transferrin concentration	Study visit 1 day
Secondary	Transferrin saturation	Transferrin saturation	Study visit 1 day
Secondary	C-reactive protein	C-reactive protein	Study visit 1 day
Secondary	Vitamin B12 concentration	Vitamin B12 concentration	Study visit 1 day
Secondary	Folate (RBC level)	Folate (RBC level)	Study visit 1 day
Secondary	Folate (serum level)	Folate (serum level)	Study visit 1 day