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

NCT03784508 | Unknown

• 1 other identifier: PR(AG)320-2018
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity

Keywords

morbid obesity; bariatric surgery; psychological profile

Outcome Measures

Primary Outcomes (3)

• Evolution of the body mass index in morbidly obesity patients after bariatric surgery (BS).

  For the assessment of the evolution after bariatric surgery the investigators will use the body mass index parameter (BMI), calculated with the following formula: Body mass index (BMI) will be calculated as weight (kg)/height (m2). Changes in BMI, will be evaluated at 1, 6, 12 and 24 month after bariatric surgery.

  24month

• Evolution of the excess of weight loss % (EWL%) after bariatric surgery.

  \- Excess of weight loss % (EWL%) will be calculated using the following formula: pre-bariatric surgery weight (kg)-visit weight (kg)/pre-bariatric surgery weight (kg)- ideal weight (for BMI 25) (kg) x 100%. Changes in EWL% will be evaluated at 1, 6, 12 and 24 month after bariatric surgery.

  24 month

• Evolution of the total weight loss after bariatric surgery

  -Total weight loss (TWL) will be calculated as: pre-bariatric surgery weight (kg)- visit weight (kg). Changes in TWL will be evaluated at 1, 6, 12 and 24 month after bariatric surgery.

  24 month

Secondary Outcomes (15)

• Evaluation of the body composition scores before and after bariatric surgery by means of bioimpedanciometry.

  24 month

• Evaluation of the Advanced Glycation End products (AGEs) before and after bariatric surgery.

  24 month

• Evaluation of neuropsychological scores before and after bariatric surgery: eating attitudes

  24month

• Evaluation of neuropsychological scores before and after bariatric surgery: Attention-Deficit Hyperactivity Disorder (ADHD)

  24month

• Evaluation of neuropsychological scores before and after bariatric surgery: Sheehan Disability Inventory (SDI).

  24 month

Study Arms (1)

Bariatric surgery

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

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Andreea Ciudin

Barcelona, 08035, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples Blood samples DNA from saliva

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Andreea Ciudin, MD, PhD

CONTACT

697817352; aciudin@vhebron.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Morbid Obesity Unit and Clinical Trials Department

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: December 24, 2018
• Study Start: April 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: April 1, 2022
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)