Hepcidin Behavior in Patients With Obesity and Bariatric Surgery (HOBS)

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.

Study Overview

• Status: Terminated
• Conditions: Hepcidin
• Intervention / Treatment: Other: Blood sampling

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.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients with obesity, patients with a Sleeve Gasterctomy or patients with a Roux-en-Y Gastric Bypass

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with obesity; In 100 patients with obesity, blood samples will be collected.	Other: Blood sampling; Blood sample collection
Patients with a Sleeve Gastrectomy; In 100 patients with a Sleeve Gastrectomy, blood samples will be collected.	Other: Blood sampling; Blood sample collection
Patients with a Roux-en-Y Gastric Bypass; In 100 patients with a Roux-en-Y Gastric Bypass, blood samples will be collected.	Other: Blood sampling; Blood sample collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum hepcidin concentration	Serum hepcidin concentration	Study visit 1 day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2019
• Primary Completion (Actual): December 12, 2023
• Study Completion (Actual): December 12, 2023

Study Registration Dates

• First Submitted: June 17, 2019
• First Submitted That Met QC Criteria: June 18, 2019
• First Posted (Actual): June 19, 2019

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: S62085

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No