- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02409173
NPPV on Inflammatory Markers and Sleep in Severe Obese Patients With Metabolic Syndrome Undergone to Bariatric Surgery
2018년 6월 13일 업데이트: 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.
연구 개요
상태
알려지지 않은
정황
상세 설명
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.
연구 유형
중재적
등록 (예상)
17
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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GO
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Anápolis, GO, 브라질, 75083-515
- Gastromed
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SP
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Sao Paulo, SP, 브라질, 01221-010
- Department of Surgery of Santa Casa of Sao Paulo Medical School
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Sao Paulo, SP, 브라질, 01221010
- Pulmonary Function Laboratory of Santa Casa of Sao Paulo Medical School
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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
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: 대조군
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|
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실험적: 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.
다른 이름들:
Standard Roux-en-Y gastric bypass
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in systemic immune response
기간: Baseline immune response to 180 days.
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Systemic markers of inflammation through fasting blood samples biochemical indexes.
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Baseline immune response to 180 days.
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Change in systemic adipose inflammation response
기간: Baseline adipose inflammation response to 180 days.
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Systemic markers of inflammation through biochemical indexes in visceral (omental, mesenteric) and subcutaneous adipose tissue depots.
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Baseline adipose inflammation response to 180 days.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Prevalence of sleep disorders
기간: 180 days
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Study sleep patterns through full standard polysomnography.
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180 days
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Changes in pulmonary function
기간: 180 days
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Assess pulmonary function through pletysmography.
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180 days
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Changes in maximal ventilatory pressures
기간: 180 days
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Assess maximal inspiratory and expiratory pressures through manovacuometry.
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180 days
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Changes in health related quality of life
기간: 180 days
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Changes in quality of life through Short Form-36 and BAROS questionnaires.
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180 days
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Weight Loss
기간: 180 days
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Body mass index reduction.
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180 days
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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)
2015년 1월 1일
기본 완료 (실제)
2018년 5월 1일
연구 완료 (예상)
2020년 7월 1일
연구 등록 날짜
최초 제출
2015년 3월 24일
QC 기준을 충족하는 최초 제출
2015년 4월 3일
처음 게시됨 (추정)
2015년 4월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 6월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 6월 13일
마지막으로 확인됨
2018년 6월 1일
추가 정보
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. .
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