NPPV on Inflammatory Markers and Sleep in Severe Obese Patients With Metabolic Syndrome Undergone to Bariatric Surgery
13 juin 2018 mis à jour par: Luis Vicente Franco de Oliveira, Centro Universitário de Anapolis
Effects of Noninvasive Positive Pressure Ventilation on Inflammatory Markers, Sleep, Pulmonary Function and HRQoL in Severe Obese Patients With Metabolic Syndrome Undergone to Bariatric Surgery. A Randomized Controlled Clinical Trial
Obesity is currently one of the most serious public health problems.
Its prevalence is increasing sharply in recent decades, even in developing countries, leading to global epidemiology condition.
Metabolic syndrome (MS) consists of an association of metabolic and cardiovascular disorders including central obesity, insulin resistance, dyslipidemia and hypertension in the same patient.
Obstructive sleep apnea (OSA) is a common clinical condition in more than 60% patients with MS.
It is still controversial in the world scientific literature whether treatment of OSA with Noninvasive Positive Pressure Ventilation (NPPV) in severely obese patients with and without MS is effective.
The NPPV effectively reverses hypoxemia in patients with OSA, therefore justified the hypothesis that NPPV will reduce insulin resistance, ghrelin and resistin and raise adiponectin levels in a group of severely obese individuals with and without MS undergoing bariatric surgery.
Objectives: To investigate the effects of Noninvasive Positive Pressure Ventilation on inflammatory markers, sleep, pulmonary function, BMI reduction and health related quality of life in severe obese patients with and without metabolic syndrome undergone to bariatric surgery.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Description détaillée
Obesity is currently one of the most serious public health problems.
Its prevalence is increasing sharply in recent decades, even in developing countries, leading to global epidemiology condition.
Metabolic syndrome (MS) consists of an association of metabolic and cardiovascular disorders including central obesity, insulin resistance, dyslipidemia and hypertension in the same patient.
Obstructive sleep apnea (OSA) is a common clinical condition in more than 60% patients with MS.
It is still controversial in the world scientific literature whether treatment of OSA with Noninvasive Positive Pressure Ventilation (NPPV) in severely obese patients with and without MS is effective.
The NPPV effectively reverses hypoxemia in patients with OSA, therefore justified the hypothesis that NPPV will reduce insulin resistance, ghrelin and resistin and raise adiponectin levels in a group of severely obese individuals with and without MS undergoing bariatric surgery.
Objectives: To investigate the effects of Noninvasive Positive Pressure Ventilation on inflammatory markers, sleep, pulmonary function, BMI reduction and health related quality of life in severe obese patients with and without metabolic syndrome undergone to bariatric surgery.
Methods/Design: Will participate severe obese patients with and without MS, screened from the Bariatric Surgery Service of Santa Casa de Sao Paulo.
The inclusion criteria are patients with morbid obesity grade III, with an indication of bariatric surgery and who have agreed to the study, signing an informed consent.
Subjects with BMI above 55 kg / m², clinically significant or mental health concerns unstable, an unrealistic target postsurgical weight and/or unrealistic expectations of the surgical treatment will be excluded.
Patients will use the NPPV pre and post bariatric surgery.
The evaluation protocol will consist of clinical history, vital signs, anthropometric data, clinical analysis of blood and adipose inflammatory markers, lung function tests, polysomnography, sleep scales, cardiovascular risk and quality of life questionnaires.
Patients will be evaluated before and after bariatric surgery, 90, 180 and 360 days.
Type d'étude
Interventionnel
Inscription (Anticipé)
17
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
GO
-
Anápolis, GO, Brésil, 75083-515
- Gastromed
-
-
SP
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Sao Paulo, SP, Brésil, 01221-010
- Department of Surgery of Santa Casa of Sao Paulo Medical School
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Sao Paulo, SP, Brésil, 01221010
- Pulmonary Function Laboratory of Santa Casa of Sao Paulo Medical School
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- male and female patients aged 18 to 65 years,
- grade III severe obesity (BMI ≥ 40 kg/m2) or ≥ 35 kg/m2 with comorbidities,
- awaiting bariatric surgery,
- with documented history of conventional weight loss attempts having proven unsuccessful over time,
- sleep apnea history verified through polysomnography
- and if they are able to understand and agreement to participate in the study through a signed term of informed consent.
Exclusion Criteria:
- Any medical condition rendering surgery too risky,
- BMI above 55 kg/m2,
- unrealistic postoperative target weight and/or unrealistic expectations of surgical treatment,
- pregnancy,
- lactation or planned pregnancy within two years of potential surgical treatment,
- lack of safe access to abdominal cavity or gastrointestinal tract;
- abusive alcohol use or drug use,
- craniofacial abnormalities,
- undergoing active treatment of sleep apnea,
- cancer,
- any cardiorespiratory condition opposite indicate the surgical procedure.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Groupe de contrôle
|
|
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Expérimental: Noninvasive Ventilation and Surgery
Noninvasive positive airway pressure flow generator device by full face or nasal mask and bariatric surgery.
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Noninvasive positive airway pressure flow generator device.
Autres noms:
Standard Roux-en-Y gastric bypass
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in systemic immune response
Délai: Baseline immune response to 180 days.
|
Systemic markers of inflammation through fasting blood samples biochemical indexes.
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Baseline immune response to 180 days.
|
|
Change in systemic adipose inflammation response
Délai: Baseline adipose inflammation response to 180 days.
|
Systemic markers of inflammation through biochemical indexes in visceral (omental, mesenteric) and subcutaneous adipose tissue depots.
|
Baseline adipose inflammation response to 180 days.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Prevalence of sleep disorders
Délai: 180 days
|
Study sleep patterns through full standard polysomnography.
|
180 days
|
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Changes in pulmonary function
Délai: 180 days
|
Assess pulmonary function through pletysmography.
|
180 days
|
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Changes in maximal ventilatory pressures
Délai: 180 days
|
Assess maximal inspiratory and expiratory pressures through manovacuometry.
|
180 days
|
|
Changes in health related quality of life
Délai: 180 days
|
Changes in quality of life through Short Form-36 and BAROS questionnaires.
|
180 days
|
|
Weight Loss
Délai: 180 days
|
Body mass index reduction.
|
180 days
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 janvier 2015
Achèvement primaire (Réel)
1 mai 2018
Achèvement de l'étude (Anticipé)
1 juillet 2020
Dates d'inscription aux études
Première soumission
24 mars 2015
Première soumission répondant aux critères de contrôle qualité
3 avril 2015
Première publication (Estimation)
6 avril 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 juin 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 juin 2018
Dernière vérification
1 juin 2018
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 742.865/2014
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