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

8 de fevereiro de 2021 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Obesidade mórbida

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Antecipado)

200

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: Andreea Ciudin, MD, PhD
Número de telefone: 697817352
E-mail: aciudin@vhebron.net

Locais de estudo

Espanha
- - Barcelona, Espanha, 08035
    - Recrutamento
    - Andreea Ciudin
    - Contato:
      
      Andreea Ciudin, MD, PhD
      
      Número de telefone: 697817352
      
      E-mail: aciudin@vhebron.net
    - Contato:
      
      Diana Romero Godoy, Nurse
      
      E-mail: diana.romero@vhir.org
    - Subinvestigador:
      
      Diana Romero Godoy, Nurse
    - Subinvestigador:
      
      Enzamaria Fidilio, MD
    - Investigador principal:
      
      Andreea Ciudin, MD, PhD
    - Subinvestigador:
      
      Angel Ortiz, MD
    - Subinvestigador:
      
      Marta Comas, Dietis
    - Subinvestigador:
      
      Marta Sanchez, MD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 65 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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).

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Modelos de observação: Coorte
Perspectivas de Tempo: Prospectivo

Número de grupos/coortes

Coortes e Intervenções

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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Evolution of the body mass index in morbidly obesity patients after bariatric surgery (BS). Prazo: 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. Prazo: 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 Prazo: 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

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Evaluation of the body composition scores before and after bariatric surgery by means of bioimpedanciometry. Prazo: 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. Prazo: 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 Prazo: 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) Prazo: 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). Prazo: 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). Prazo: 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. Prazo: 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. Prazo: 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. Prazo: 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). Prazo: 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). Prazo: 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). Prazo: 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) Prazo: 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 Prazo: 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 Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Hospital Universitari Vall d'Hebron Research Institute

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de abril de 2018

Conclusão Primária (Antecipado)

31 de dezembro de 2021

Conclusão do estudo (Antecipado)

1 de abril de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

4 de setembro de 2018

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de dezembro de 2018

Primeira postagem (Real)

24 de dezembro de 2018

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de fevereiro de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de fevereiro de 2021

Última verificação

1 de fevereiro de 2021

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

PR(AG)320-2018

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Não

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .