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NPPV on Inflammatory Markers and Sleep in Severe Obese Patients With Metabolic Syndrome Undergone to Bariatric Surgery

13 juni 2018 uppdaterad av: 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

17

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • GO
      • Anápolis, GO, Brasilien, 75083-515
        • Gastromed
    • SP
      • Sao Paulo, SP, Brasilien, 01221-010
        • Department of Surgery of Santa Casa of Sao Paulo Medical School
      • Sao Paulo, SP, Brasilien, 01221010
        • Pulmonary Function Laboratory of Santa Casa of Sao Paulo Medical School

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Kontrollgrupp
Experimentell: Noninvasive Ventilation and Surgery
Noninvasive positive airway pressure flow generator device by full face or nasal mask and bariatric surgery.
Noninvasive positive airway pressure flow generator device.
Andra namn:
  • Noninvasive Positive Pressure Ventilation
Standard Roux-en-Y gastric bypass

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in systemic immune response
Tidsram: Baseline immune response to 180 days.
Systemic markers of inflammation through fasting blood samples biochemical indexes.
Baseline immune response to 180 days.
Change in systemic adipose inflammation response
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Prevalence of sleep disorders
Tidsram: 180 days
Study sleep patterns through full standard polysomnography.
180 days
Changes in pulmonary function
Tidsram: 180 days
Assess pulmonary function through pletysmography.
180 days
Changes in maximal ventilatory pressures
Tidsram: 180 days
Assess maximal inspiratory and expiratory pressures through manovacuometry.
180 days
Changes in health related quality of life
Tidsram: 180 days
Changes in quality of life through Short Form-36 and BAROS questionnaires.
180 days
Weight Loss
Tidsram: 180 days
Body mass index reduction.
180 days

Samarbetspartners och utredare

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 januari 2015

Primärt slutförande (Faktisk)

1 maj 2018

Avslutad studie (Förväntat)

1 juli 2020

Studieregistreringsdatum

Först inskickad

24 mars 2015

Först inskickad som uppfyllde QC-kriterierna

3 april 2015

Första postat (Uppskatta)

6 april 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

15 juni 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 juni 2018

Senast verifierad

1 juni 2018

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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