Identification of Biomarkers of Response After Bariatric Surgery in Morbidly Obese Patients (PREDI-BAR)
2021年2月8日 更新者：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.
調査の概要
状態
募集
条件
詳細な説明
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.
研究の種類
観察的
入学 (予想される)
200
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Andreea Ciudin, MD, PhD
- 電話番号：697817352
- メール：aciudin@vhebron.net
研究場所
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-
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Barcelona、スペイン、08035
- 募集
- Andreea Ciudin
-
コンタクト：
- Andreea Ciudin, MD, PhD
- 電話番号：697817352
- メール：aciudin@vhebron.net
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コンタクト：
- Diana Romero Godoy, Nurse
- メール：diana.romero@vhir.org
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副調査官：
- Diana Romero Godoy, Nurse
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副調査官：
- Enzamaria Fidilio, MD
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主任研究者：
- Andreea Ciudin, MD, PhD
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副調査官：
- Angel Ortiz, MD
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副調査官：
- Marta Comas, Dietis
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副調査官：
- Marta Sanchez, MD
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
|---|
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Bariatric surgery
200 consecutive patients that will undergo bariatric surgery as a routinary procedure at our site
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Evolution of the body mass index in morbidly obesity patients after bariatric surgery (BS).
時間枠：24month
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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
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Evolution of the excess of weight loss % (EWL%) after bariatric surgery.
時間枠：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.
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24 month
|
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Evolution of the total weight loss after bariatric surgery
時間枠：24 month
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-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.
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24 month
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Evaluation of the body composition scores before and after bariatric surgery by means of bioimpedanciometry.
時間枠：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.
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24 month
|
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Evaluation of the Advanced Glycation End products (AGEs) before and after bariatric surgery.
時間枠：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
|
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Evaluation of neuropsychological scores before and after bariatric surgery: eating attitudes
時間枠：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.
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24month
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Evaluation of neuropsychological scores before and after bariatric surgery: Attention-Deficit Hyperactivity Disorder (ADHD)
時間枠：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.
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24month
|
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Evaluation of neuropsychological scores before and after bariatric surgery: Sheehan Disability Inventory (SDI).
時間枠：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.
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24 month
|
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Evaluation of neuropsychological scores before and after bariatric surgery: Zuckerman-Kuhlman Personality Questionnaire (ZKPQ).
時間枠：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.
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24month
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Evaluation of neuropsychological scores before and after bariatric surgery: COPE- stress management strategies.
時間枠：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.
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24month
|
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Evaluation of neuropsychological scores before and after bariatric surgery: ROTTER´s locus of control scale.
時間枠：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.
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24month
|
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Evaluation of neuropsychological scores before and after bariatric surgery: YALE food addiction.
時間枠：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.
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24month
|
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Evaluation of neuropsychological scores before and after bariatric surgery:The Bariatric Analysis and Reporting Outcome System (B.A.R.OS).
時間枠：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.
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24month
|
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Evaluation of neuropsychological scores before and after bariatric surgery: The State-Trait Anxiety Inventory (STAI).
時間枠：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.
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24month
|
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Evaluation of neuropsychological scores before and after bariatric surgery: WPAI (working productivity questionnaire).
時間枠：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.
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24month
|
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Evaluation of neuropsychological scores before and after bariatric surgery: Beck Depression Inventory (BDI)
時間枠：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.
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24month
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Evaluation of the congnitive function before and after bariatric surgery
時間枠：24 month
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Minimental State Evaluation Test and Montreal Cognitive Assessment test will be used before and at 12 and 24 month after bariatric surgery
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24 month
|
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Evaluation of the utility of the retinal function evaluation in the detection of cognitive disfunction before and after bariatric surgery
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年4月1日
一次修了 (予想される)
2021年12月31日
研究の完了 (予想される)
2022年4月1日
試験登録日
最初に提出
2018年9月4日
QC基準を満たした最初の提出物
2018年12月19日
最初の投稿 (実際)
2018年12月24日
学習記録の更新
投稿された最後の更新 (実際)
2021年2月10日
QC基準を満たした最後の更新が送信されました
2021年2月8日
最終確認日
2021年2月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。