Hepcidin Behavior in Patients With Obesity and Bariatric Surgery
- Conditions
- Hepcidin
- Interventions
- Other: Blood sampling
- Registration Number
- NCT03990948
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with obesity Blood sampling In 100 patients with obesity, blood samples will be collected. Patients with a Sleeve Gastrectomy Blood sampling In 100 patients with a Sleeve Gastrectomy, blood samples will be collected. Patients with a Roux-en-Y Gastric Bypass Blood sampling In 100 patients with a Roux-en-Y Gastric Bypass, blood samples will be collected.
- Primary Outcome Measures
Name Time Method Serum hepcidin concentration Study visit 1 day Serum hepcidin concentration
- Secondary Outcome Measures
Name Time Method Ferritin concentration Study visit 1 day Ferritin concentration
Vitamin B12 concentration Study visit 1 day Vitamin B12 concentration
Folate (RBC level) Study visit 1 day Folate (RBC level)
Hemoglobin concentration Study visit 1 day Hemoglobin concentration
Mean corpuscular volume Study visit 1 day Mean corpuscular volume
Iron concentration Study visit 1 day Iron concentration
Transferrin concentration Study visit 1 day Transferrin concentration
Transferrin saturation Study visit 1 day Transferrin saturation
Folate (serum level) Study visit 1 day Folate (serum level)
C-reactive protein Study visit 1 day C-reactive protein
Trial Locations
- Locations (1)
UZ Leuven
🇧🇪Leuven, Belgium