Public trial
RBR-9k9hhv Study of sleep, respiratory control during sleep and quality of life in morbidly obese subjects undergoing bariatric…
Date of registration: 07/11/2011 (mm/dd/yyyy)Last approval date : 07/11/2011 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
en
Sleep study, respiratory mechanics, chemosensitive response and quality of life in morbidly obese patients undergoing bariatric surgery: A prospective, randomized, controlled
pt-br
Estudo do sono, resposta quimiossensitiva e qualidade de vida em pacientes obesos submetidos a cirurgia bariátrica: Prospectivo, randomizado, controlado
Trial identification
- UTN code: U1111-1121-9008
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Public title:
en
Study of sleep, respiratory control during sleep and quality of life in morbidly obese subjects undergoing bariatric surgery.
pt-br
Estudo do sono, do controle da respiração durante o sono e qualidade de vida em sujeitos obesos submetidos a cirurgia bariátrica.
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Scientific acronym:
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Public acronym:
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Secondaries identifiers:
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220506/2009
Issuing authority: Human Research Ethics Committee of the Nove de Julho University (Brazil)
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481169/2008-3
Issuing authority: Conselho Nacional de Desenvolvimento Cientifico e Tecnologico (local acronym CNPq), Brazil. Research Productivity modality
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220506/2009
Sponsors
- Primary sponsor: Universidade Nove de Julho - UNINOVE
- Secondary sponsor:
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Supporting source:
- Institution: Conselho Nacional de Desenvolvimento Cientifico e Tecnologico (local acronym CNPq)
Health conditions
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Health conditions:
en
We will study subjects with morbid obesity, considered nutritional and metabolic disease, undergone bariatric surgery, for investigation of sleep disorders, especially obstructive sleep apnea.
pt-br
Serão estudados sujeitos portadores de obesidade mórbida, considerada doença nutricional e metabólica, submetidos a cirurgia bariátrica, para a investigação dos transtornos do sono, especialmente a apnéia obstrutiva do sono.
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General descriptors for health conditions:
en
C08 Respiratory tract diseases
pt-br
C08 Doenças respiratórias
es
C08 Enfermedades respiratorias
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C18 Nutritional and metabolic diseases
pt-br
C18 Doenças nutricionais e metabólicas
es
C18 Enfermedades nutricionales y metabólicas
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Specific descriptors:
Interventions
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Interventions:
en
Subjects morbid obese undergone bariatric surgery will be asked to participe in the study. All the subjects' evaluations will occur prior to the surgical intervention and 30, 90 and 360 days following the procedure. All subjects in both groups will be submitted to the following evaluation protocol. General clinical measurements will be performed include body weight (kg), height (m), calculation of body mass index (BMI) using the formula weight/height2, circumferences (cm) of the neck, waist, and hip, heart and respiratory rates, blood pressure values, Mallampati index, tonsil index , the administration of specific questionnaires for sleep apnoea and excessive daytime sleepiness and a quality of life questionnaire and standart overnight polysomnography. The intervention group will be composed of subjects who underwent bariatric surgery and control groups by the subjects that will not be subjected to surgery due to the extensive waiting list associated with small service demand, although they are suited to the surgical procedure.
pt-br
Serão convidados a participar do estudo sujeitos obesos mórbidos que serão submetidos a cirurgia bariátrica. Os sujeitos serão avaliados antes e 30, 90 e 360 dias após a cirurgia. O grupo intervenção será composto pelos sujeitos submetidos à cirúrgia bariátrica e o grupo controle pelos sujeitos que não serão submetidos ao procedimento cirúrgico devido ao motivo de uma extensa fila de espera face a pequena demanda do serviço, embora estejam aptos ao procedimento cirúrgico. Todos os sujeitos dos dois grupos serão submetidos ao mesmo protocolo de avaliação. Serão realizadas avaliações clínicas (peso corporal (kg), altura (m), o cálculo da massa corporal (IMC), utilizando a fórmula peso/altura2, circunferências (cm) do pescoço, cintura e quadril, as freqüências cardíaca e respiratória, os valores da pressão arterial, índice de Mallampati, o índice de tonsila), administração de questionários específicos para a apnéia do sono e sonolência diurna excessiva e um questionário de qualidade de vida e realização de polissonografia noturna completa.
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Descriptors:
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E02.065.062 Bariatric Surgery
pt-br
E02.065.062 Cirurgia Bariátrica
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E02.065.062 Cirugía Bariátrica
Recruitment
- Study status: recruiting
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Countries
- Brazil
- Date first enrollment: 12/31/1969 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 17 - 18 Y 65 Y -
Inclusion criteria:
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Grade III morbid obesity (BMI between 40 and 55 kg/m²) or between 35 and 39 kg/m² with comorbidities; Both gender patients aged 18 to 65 years; Documented history of conventional weight loss attempts having proven unsuccessful over time; Agreement to participate in the study through a signed term of informed consent.
pt-br
Obesos móbidos grau III (IMC entre 40 e 55kg/m²) ou de 35 a 39 kg/m² associados a comorbidades; Ambos os sexos com idade entre 18 à 65 anos; História de perda de peso por métodos convencionais sem sucesso; Aceitar em participar do estudo e assinar o termo de consentimento livre e esclarecido.
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Exclusion criteria:
en
Any medical condition rendering surgery too risk; Clinically significant or unstable mental health concerns; Pregnancy, lactation or planned pregnancy within two years of potential surgical treatment; Smokers (at least 8 weeks prior to surgery), abusive alcohol use and/or drugs use.
pt-br
Condição de risco cirúrgico; Instabilidade clínica e mental; Gravidez, lactação ou gravidez planejada dentro de dois anos após procedimento cirúrgico; Fumantes (pelo menos 8 semanas antes da cirurgia), uso abusivo de álcool e ou drogas.
Study type
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Study design:
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase treatment parallel 2 single-blind randomized-controlled N/A
Outcomes
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Primary outcomes:
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Apnea/hypopnea index by standard overnight polysomnography. Sleep study will be performed with an standard overnight polysomnography monitoring system recording EEG, EMG and EOG, thoracic and abdominal movements by strain gauges, oro-nasal airflow by thermistor, snoring, body position, heart rate by cardiotachography, and pulse oximetry. An apnea was defined as the absence of airflow for more than 10 seconds and classified as central in the absence of thoraco-abdominal movements. Hypopnea was defined as a 50% decrease of airflow and thoraco-abdominal movements with a consensual oxyhaemoglobin desaturation, and classified as central hypopnea in the absence of paradoxical movements of thorax and abdomen.
pt-br
Índice de apneia/hipopneia avaliado através da polissonografia basal noturna.
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Slope of ventilatory response to carbon dioxide performed by spirometry. The rebreathing test was performed according to Read technique. Patients breathed through a mouthpiece and, after a steady state was achieved, basal ventilation was recorded for three minutes. Then patients started to breath connected to a 15 L latex balloon filled with a 7% CO2 and 93% O2 mixture for five minutes or until an end-tidal CO2 pressure PetCO2 of 70 mm Hg was reached or until exhaustion. Data were acquired by a metabolic cart (Vmax 29c, Sensor Medics, USA) and the slope of ventilatory response to carbon dioxide was obtained from the linear regression between ventilation and PetCO2. Data were adjusted by a 0.9 correction factor to correct flow readings for hyperoxic gas mixture.
pt-br
Intensidade da resposta ventilatória ao dióxido de carbono verificada através da espirometria utilizando a técnica de re-inalação de Read.
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Secondary outcomes:
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The measurements of waist and neck circumference at physical exam.
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Medidas em centímetros da circunferência da cintura e do pescoço.
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Thorax and abdomen cirtometry at physical exam.
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Mensuração das circunferências do Tórax e do Abdomem.
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Maximal inspiratory pressure and maximal expiratory pressure evaluated by digital manovacuometer.
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Pressões máximas ventilatórias geradas pelos músculos inspiratórios e expiratórios mensuradas através de manovacuometro digital.
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Evaluation of diurnal sleepiness intensity by the Epworth Sleepiness Scale.
pt-br
Avaliação da intensidade de sonolência diurna atrávés da Escala de Sonolência de Epworth.
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Evaluation of the risk to obstructive sleep apnea through Berlin Questionn
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Avaliação de risco para apneia obstrutiva do sono através do Questionário de Berlin.
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Evaluation of quality of life, weight loss percentage and changes in medical conditions through the Bariatric Analysis and Reporting Outcome System (Baros).
pt-br
Avaliação da qualidade de vida , porcentagem de perda de peso e alterações nas condições gerais de saúde através do questionário Bariatric Analysis and Reporting Outcome System (Baros).
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Weight loss evaluated by Body mass index.
pt-br
Perda de peso verificada através do Índice de massa corpórea.
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Sleep physiological variables assessed by the standart overnight polysomnography.
pt-br
Variáveis fisiológicas do sono avaliadas através da polissonografia basal noturna.
Contacts
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Public contact
- Full name: Luis Vicente Franco Oliveira
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- Address: Avenida Francisco Matarazzo, 612 - Agua Branca
- City: Sao Paulo / Brazil
- Zip code: 05001100
- Phone: +551136659890
- Email: oliveira.lvf@uninove.br
- Affiliation: Universidade Nove de Julho - UNINOVE
- Full name: Luis Vicente Franco Oliveira
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- Address: Avenida Francisco Matarazzo, 612 - Agua Branca
- City: São Paulo / Brazil
- Zip code: 05001100
- Phone: +551136659890
- Email: oliveira.lvf@uninove.br
- Affiliation: Universidade Nove de Julho - UNINOVE
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Scientific contact
- Full name: Luis Vicente Franco Oliveira
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- Address: Avenida Francisco Matarazzo, 612 - Agua Branca
- City: Sao Paulo / Brazil
- Zip code: 05001100
- Phone: +551136659890
- Email: oliveira.lvf@uninove.br
- Affiliation: Universidade Nove de Julho - UNINOVE
- Full name: Luis Vicente Franco Oliveira
-
- Address: Avenida Francisco Matarazzo, 612 - Agua Branca
- City: São Paulo / Brazil
- Zip code: 05001100
- Phone: +551136659890
- Email: oliveira.lvf@uninove.br
- Affiliation: Universidade Nove de Julho - UNINOVE
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Site contact
- Full name: Luis Vicente Franco Oliveira
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- Address: Avenida Francisco Matarazzo, 612 - Agua Branca
- City: Sao Paulo / Brazil
- Zip code: 05001100
- Phone: +551136659890
- Email: oliveira.lvf@uninove.br
- Affiliation: Universidade Nove de Julho - UNINOVE
Additional links:
Total de Ensaios Clínicos 13168.
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