Hepcidin Behavior in Patients With Obesity and Bariatric Surgery

NCT ID: NCT03990948

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-08

Study Completion Date

2023-12-12

Brief Summary

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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

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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.

Conditions

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Hepcidin

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with obesity

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

Blood sampling

Intervention Type OTHER

Blood sample collection

Patients with a Sleeve Gastrectomy

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

Blood sampling

Intervention Type OTHER

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.

Blood sampling

Intervention Type OTHER

Blood sample collection

Interventions

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Blood sampling

Blood sample collection

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UZ Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S62085

Identifier Type: -

Identifier Source: org_study_id

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