Clinical trial NCT03784508: Identification of Biomarkers of Response After Bariatric Surgery in Morbidly Obese Patients
Official title: Identification of Biomarkers of Response After Bariatric Surgery in Morbidly Obese Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Morbid Obesity
Keywords: morbid obesity
bariatric surgery
psychological profile
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients that are attended at our outpatient clinic of the Morbid Obesity Unit of Vall Hebron University Hospital, that will undergo BS between September 2018 and December 2019.

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Evolution of the body mass index in morbidly obesity patients after bariatric surgery (BS).
timeFrame: 24month
measure: Evolution of the excess of weight loss % (EWL%) after bariatric surgery.
timeFrame: 24 month
measure: Evolution of the total weight loss after bariatric surgery
timeFrame: 24 month
Secondary outcomes:
measure: Evaluation of the body composition scores before and after bariatric surgery by means of bioimpedanciometry.
timeFrame: 24 month
measure: Evaluation of the Advanced Glycation End products (AGEs) before and after bariatric surgery.
timeFrame: 24 month
measure: Evaluation of neuropsychological scores before and after bariatric surgery: eating attitudes
timeFrame: 24month
measure: Evaluation of neuropsychological scores before and after bariatric surgery: Attention-Deficit Hyperactivity Disorder (ADHD)
timeFrame: 24month
measure: Evaluation of neuropsychological scores before and after bariatric surgery: Sheehan Disability Inventory (SDI).
timeFrame: 24 month
measure: Evaluation of neuropsychological scores before and after bariatric surgery: Zuckerman-Kuhlman Personality Questionnaire (ZKPQ).
timeFrame: 24month
measure: Evaluation of neuropsychological scores before and after bariatric surgery: COPE- stress management strategies.
timeFrame: 24month
measure: Evaluation of neuropsychological scores before and after bariatric surgery: ROTTER´s locus of control scale.
timeFrame: 24month
measure: Evaluation of neuropsychological scores before and after bariatric surgery: YALE food addiction.
timeFrame: 24month
measure: Evaluation of neuropsychological scores before and after bariatric surgery:The Bariatric Analysis and Reporting Outcome System (B.A.R.OS).
timeFrame: 24month
measure: Evaluation of neuropsychological scores before and after bariatric surgery: The State-Trait Anxiety Inventory (STAI).
timeFrame: 24month
measure: Evaluation of neuropsychological scores before and after bariatric surgery: WPAI (working productivity questionnaire).
timeFrame: 24month
measure: Evaluation of neuropsychological scores before and after bariatric surgery: Beck Depression Inventory (BDI)
timeFrame: 24month
measure: Evaluation of the congnitive function before and after bariatric surgery
timeFrame: 24 month
measure: Evaluation of the utility of the retinal function evaluation in the detection of cognitive disfunction before and after bariatric surgery
timeFrame: 24 month
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Andreea Ciudin
Study officials:
References: