Clinical trial NCT03990948: Hepcidin Behavior in Patients With Obesity and Bariatric Surgery
Official title: Hepcidin Behavior in Patients With Obesity and Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepcidin
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with obesity, patients with a Sleeve Gasterctomy or patients with a Roux-en-Y Gastric Bypass

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.

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

Primary outcomes:
measure: Serum hepcidin concentration
timeFrame: Study visit 1 day
Secondary outcomes:
measure: Hemoglobin concentration
timeFrame: Study visit 1 day
measure: Mean corpuscular volume
timeFrame: Study visit 1 day
measure: Iron concentration
timeFrame: Study visit 1 day
measure: Ferritin concentration
timeFrame: Study visit 1 day
measure: Transferrin concentration
timeFrame: Study visit 1 day
measure: Transferrin saturation
timeFrame: Study visit 1 day
measure: C-reactive protein
timeFrame: Study visit 1 day
measure: Vitamin B12 concentration
timeFrame: Study visit 1 day
measure: Folate (RBC level)
timeFrame: Study visit 1 day
measure: Folate (serum level)
timeFrame: Study visit 1 day
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References: