- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02409173
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
Status
Okänd
Betingelser
Intervention / Behandling
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
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Sao Paulo, SP, Brasilien, 01221-010
- Department of Surgery of Santa Casa of Sao Paulo Medical School
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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:
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.
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180 days
|
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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.
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180 days
|
|
Weight Loss
Tidsram: 180 days
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Body mass index reduction.
|
180 days
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
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
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 742.865/2014
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