Identification of Biomarkers of Response After Bariatric Surgery in Morbidly Obese Patients

NCT ID: NCT03784508

Last Updated: 2021-02-10

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

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2022-04-01

Brief Summary

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The prevalence of obesity in Spain is about 21.6%. The discouraging results provided by dietary treatment, together with the lack of funding for pharmacological treatment, have led to the progressive use of bariatric surgery (CB). Besides weight loss, CB associates a beneficial effect on metabolic comorbidities. However, 25-30% of operated patients present a weight response considered inappropriate, they do not resolve their comorbidities and/or present a weight-regain shortly after surgery. Therefore, predictive strategies are necessary to allow a correct selection of obese patients who are candidates for CB.

The main hypothesis of the study is that various factors such as psychopathological profile, body composition and metabolic alterations related to morbid obesity can influence the response to bariatric surgery.

Detailed Description

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The investigators have designed a prospective study in which 200 consecutive patients from the outpatient clinic of the Morbidly Obesity Unit of the Vall d'Hebron Hospital will be included, meeting criteria for bariatric surgery (with BMI\> 40 kg / m2 or BMI\> 35 kg /m2 in the presence of comorbidities) and will undergo surgery in the investigator's center between September 2018 and September 2019. All patients will undergo (baseline, month, 6, 12 and 24 month): complete clinical history, analysis complete biochemistry, 2 blood samples will be extracted to study metabolomics, stool sample for microbiota study, bioimpedance for the study of body composition, determination of AGEs in the skin and lens, cognitive function assessment, retinal function assessment by microperimetry and they will be asked to complete several specific questionnaires for the evaluation of the psychopathological profile and the dietetic survey.

Conditions

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Morbid Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Bariatric surgery

200 consecutive patients that will undergo bariatric surgery as a routinary procedure at our site

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients fulfilling criteria for bariatric surgery (BS).
* Signed informed consent fir the BS and the study.
* Previous accomplishment of the preoperative protocol for the BS at our site.
* undergo BS between September 2018 and December 2019
* Able to read and understand the specific questionnaires.

Exclusion Criteria

* Any contraindication for the bariatric surgery.
* Impossibility to follow-up at our site (eg: patients from outside out community).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Andreea Ciudin

Head of the Morbid Obesity Unit and Clinical Trials Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Andreea Ciudin

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Andreea Ciudin, MD, PhD

Role: CONTACT

697817352

Facility Contacts

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Andreea Ciudin, MD, PhD

Role: primary

697817352

Diana Romero Godoy, Nurse

Role: backup

Other Identifiers

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PR(AG)320-2018

Identifier Type: -

Identifier Source: org_study_id

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