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Identification of Biomarkers of Response After Bariatric Surgery in Morbidly Obese Patients (PREDI-BAR)

V

Vall d'Hebron University Hospital (HUVH)

Status

Unknown

Conditions

Morbid Obesity

Study type

Observational

Funder types

Other

Identifiers

NCT03784508
PR(AG)320-2018

Details and patient eligibility

About

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.

Full description

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

200 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Andreea Ciudin, MD, PhD

Data sourced from clinicaltrials.gov

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