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Clinical Trials/NCT03990948
NCT03990948
Terminated
Not Applicable

Hepcidin Behavior in Patients With Obesity and Bariatric Surgery

Universitaire Ziekenhuizen KU Leuven1 site in 1 country300 target enrollmentJanuary 8, 2019
ConditionsHepcidin

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hepcidin
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
300
Locations
1
Primary Endpoint
Serum hepcidin concentration
Status
Terminated
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 8, 2019
End Date
December 12, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Serum hepcidin concentration

Time Frame: Study visit 1 day

Serum hepcidin concentration

Secondary Outcomes

  • Hemoglobin concentration(Study visit 1 day)
  • Mean corpuscular volume(Study visit 1 day)
  • Folate (serum level)(Study visit 1 day)
  • Iron concentration(Study visit 1 day)
  • Transferrin concentration(Study visit 1 day)
  • Transferrin saturation(Study visit 1 day)
  • Ferritin concentration(Study visit 1 day)
  • Vitamin B12 concentration(Study visit 1 day)
  • Folate (RBC level)(Study visit 1 day)
  • C-reactive protein(Study visit 1 day)

Study Sites (1)

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