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

2021년 2월 8일 업데이트: Andreea Ciudin, Hospital Universitari Vall d'Hebron Research Institute

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.

연구 개요

상태

모병

정황

병적 비만

상세 설명

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.

연구 유형

관찰

등록 (예상)

200

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Andreea Ciudin, MD, PhD
전화번호: 697817352
이메일: aciudin@vhebron.net

연구 장소

스페인
- - Barcelona, 스페인, 08035
    - 모병
    - Andreea Ciudin
    - 연락하다:
      
      Andreea Ciudin, MD, PhD
      
      전화번호: 697817352
      
      이메일: aciudin@vhebron.net
    - 연락하다:
      
      Diana Romero Godoy, Nurse
      
      이메일: diana.romero@vhir.org
    - 부수사관:
      
      Diana Romero Godoy, Nurse
    - 부수사관:
      
      Enzamaria Fidilio, MD
    - 수석 연구원:
      
      Andreea Ciudin, MD, PhD
    - 부수사관:
      
      Angel Ortiz, MD
    - 부수사관:
      
      Marta Comas, Dietis
    - 부수사관:
      
      Marta Sanchez, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

관찰 모델: 보병대
시간 관점: 유망한

그룹/코호트 수

코호트 및 개입

그룹/코호트
Bariatric surgery 200 consecutive patients that will undergo bariatric surgery as a routinary procedure at our site

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Evolution of the body mass index in morbidly obesity patients after bariatric surgery (BS). 기간: 24month	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. 기간: 24 month	- 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 기간: 24 month	-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

2차 결과 측정

결과 측정	측정값 설명	기간
Evaluation of the body composition scores before and after bariatric surgery by means of bioimpedanciometry. 기간: 24 month	All the patients will undergo before and after bariatric surgery (after 1,6, 12, and 24 month) the bioimpedance Bodystat QuadScan 4000 evaluation. The results are expressed in kg of free fatty mass and fatty mass. The change in Kg of the free fatty mass and fatty mass regarding the baseline will be evaluated.	24 month
Evaluation of the Advanced Glycation End products (AGEs) before and after bariatric surgery. 기간: 24 month	All the patients will undergo AGEs evaluation before, at 6, 12, 24 months after bariatric surgery (eye and skin using CLEARPATH DS-120 and microCAYA-AGEreader respectively). The presence of the AGEs is automatically calculated as standard deviation from the normal values for age and gender. The differences between the baseline value, at 6,12 and 24 month will be evaluated.	24 month
Evaluation of neuropsychological scores before and after bariatric surgery: eating attitudes 기간: 24month	Eating Attitudes Test (EAT) evaluates the possible eating disorders of the patients. The test will be used before, at 6, 12, and 24month after bariatric surgery and the scores will be compared. The investigators will search for correlations with the BMI, EWL% and TWL changes. The subjects will have to answer 40 items, each of it measured from 0 to 3, total score may range between 0 and 120. The accepted cut-off for diagnosis eating disorders is more than 20 for spanish population.	24month
Evaluation of neuropsychological scores before and after bariatric surgery: Attention-Deficit Hyperactivity Disorder (ADHD) 기간: 24month	ADHD rating scale will be used before, at 6, 12, and 24month after bariatric surgery and the scores will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. The scale ranges between 0-27 points, the highest the value, the higher de attention deficit and hyperactivity.	24month
Evaluation of neuropsychological scores before and after bariatric surgery: Sheehan Disability Inventory (SDI). 기간: 24 month	Sheehan Disability Inventory (SDI) scale will be used before, at 6, 12, and 24month after bariatric surgery and the scores will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. The Sheehan Disability Inventory evaluates the social fobia and the score ranges between 0-30. A score > 15 is considered pathological.	24 month
Evaluation of neuropsychological scores before and after bariatric surgery: Zuckerman-Kuhlman Personality Questionnaire (ZKPQ). 기간: 24month	ZKPQ personality evaluation will be used before, at 6, 12, and 24month after bariatric surgery and the scores will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. ZKPQ is a quantitative scale which evaluates 6 personality dimensions: aggressivity (19 points), anxiety (19 points), impulsivity (17 points), activity (17 points), sociability (17 points). There is no clear cut-off for this test. In consequence, there will be evaluated only the changes after the bariatric surgery, compared with the baseline score. The higher the score the higher the personality disorder.	24month
Evaluation of neuropsychological scores before and after bariatric surgery: COPE- stress management strategies. 기간: 24month	COPE test will be used before, at 6, 12, and 24month after bariatric surgery and the scores will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. COPE is a quantitative scale which evaluates 15 strategies of stress coping. The total score ranges between 15-60 points. There is a direct relation between the score and the ability to manage the stress, but no clear cut-off for this test exists. In consequence, we will only evaluate the changes after the bariatric surgery regarding the baseline score. The highest score indicates better strategies to cope the stress.	24month
Evaluation of neuropsychological scores before and after bariatric surgery: ROTTER´s locus of control scale. 기간: 24month	ROTTER´s locus of control scale test will be used before, at 6, 12, and 24month after bariatric surgery and the scores will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. COPE is a quantitative scale which a total score ranging between 0-29 points. The cut-off value <15 defines the internal locus of control.	24month
Evaluation of neuropsychological scores before and after bariatric surgery: YALE food addiction. 기간: 24month	YALE food addiction scale test will be used before, at 6, 12, and 24month after bariatric surgery and the scores will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. There is a direct relation between the score and the food addiction, is a quantitative scale but there is no clear cut-off. There will be evaluated the changes in the score at 6,12, and 24 month after the bariatric surgery, comparing with baseline. The highest the score, the higher the food addiction.	24month
Evaluation of neuropsychological scores before and after bariatric surgery:The Bariatric Analysis and Reporting Outcome System (B.A.R.OS). 기간: 24month	B.A.R.O.S test will be used before, at 6, 12, and 24month after bariatric surgery and the scores will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. B.A.R.O.S. is a quantitative questionnaire evaluating the quality of life after the bariatric surgery. The scale ranges between 0 and 9. The higher the score the highest the quality of life of the patient.	24month
Evaluation of neuropsychological scores before and after bariatric surgery: The State-Trait Anxiety Inventory (STAI). 기간: 24month	STAI anxiety questionnaire evaluates the degree of the anxiety of the patient and will be used before, at 6, 12, and 24month after bariatric surgery and the scores will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. The score ranges between 0 and 60. A cut-off value> 19 is considered pathological anxiety.	24month
Evaluation of neuropsychological scores before and after bariatric surgery: WPAI (working productivity questionnaire). 기간: 24month	WPAI questionnaire will be used before, at 6, 12, and 24month after bariatric surgery and the results will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. There is a qualitative score, evaluating the working status of the patient: retiree, active, off-work>6month, unemployed, permanent occupational disability. Percentages of each category will be evaluated at each time. Ej: % of unemployed, etc.	24month
Evaluation of neuropsychological scores before and after bariatric surgery: Beck Depression Inventory (BDI) 기간: 24month	BDI evaluates if depression exists and its degree. It will be used before, at 6, 12, and 24month after bariatric surgery and the results will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. The score ranges between 0-40. 0-10: normal; 10-16 mild emotional; 17-20: borderline clinical depression; 21-30 moderate depression; 31-40 severe depression.	24month
Evaluation of the congnitive function before and after bariatric surgery 기간: 24 month	Minimental State Evaluation Test and Montreal Cognitive Assessment test will be used before and at 12 and 24 month after bariatric surgery	24 month
Evaluation of the utility of the retinal function evaluation in the detection of cognitive disfunction before and after bariatric surgery 기간: 24 month	Retinal microperimetry using MAIA 3rd generation microperimeter will be used before and at 12 and 24 month after the bariatric surgery	24 month

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hospital Universitari Vall d'Hebron Research Institute

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2018년 4월 1일

기본 완료 (예상)

2021년 12월 31일

연구 완료 (예상)

2022년 4월 1일

연구 등록 날짜

최초 제출

2018년 9월 4일

QC 기준을 충족하는 최초 제출

2018년 12월 19일

처음 게시됨 (실제)

2018년 12월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 2월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 2월 8일

마지막으로 확인됨

2021년 2월 1일

추가 정보

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키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

PR(AG)320-2018

개별 참가자 데이터(IPD) 계획

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약물 및 장치 정보, 연구 문서

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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .