Hepcidin Behavior in Patients With Obesity and Bariatric Surgery

NCT03990948 | Terminated

• 1 other identifier: S62085
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepcidin

Outcome Measures

Primary Outcomes (1)

• Serum hepcidin concentration

  Serum hepcidin concentration

  Study visit 1 day

Secondary Outcomes (10)

• Hemoglobin concentration

  Study visit 1 day

• Mean corpuscular volume

  Study visit 1 day

• Iron concentration

  Study visit 1 day

• Ferritin concentration

  Study visit 1 day

• Transferrin concentration

  Study visit 1 day

Study Arms (3)

Patients with obesity

In 100 patients with obesity, blood samples will be collected.

Other: Blood sampling

Patients with a Sleeve Gastrectomy

In 100 patients with a Sleeve Gastrectomy, blood samples will be collected.

Other: Blood sampling

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

Interventions

Blood sampling OTHER

Blood sample collection

Patients with a Roux-en-Y Gastric Bypass; Patients with a Sleeve Gastrectomy; Patients with obesity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 19, 2019
• Study Start: January 8, 2019
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: July 3, 2024

Record last verified: 2022-10

Locations

BE (1)