Clinical trial NCT02409160: Sleep and Immune Response in Severe Obese Patients Undergoing Bariatric Surgery.
Official title: Sleep, Pulmonary Function, Systemic and Adipose Immune Response and Quality of Life in Severe Obese Patients Undergoing Bariatric Surgery. A Protocol of Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Obesity
Morbid Obesity
Keywords: Severe Obesity
Sleep Disorders
Bariatric Surgery
Inflammation
Quality of Life
Lead sponsor: Centro Universitário de Anapolis
Sponsor class: OTHER
Collaborators: name: Irmandade da Santa Casa de Misericordia de Sao Paulo
name: Clínica de Gastroenterologia e Medicina Avançada - GASTROMED
name: Santa Casa de Misericórdia de Anápolis
First posted: 2015-04-06
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obesity is a major public health problem in developed and developing countries, causing a range of respiratory and metabolic changes. There is a strong correlation between obesity and cardiorespiratory sleep disorders. The weight loss reduces the comorbidities and improves the quality of life, but clinical treatment it is not effective for a long period. In this context, currently bariatric surgery is an option for the real weight loss in the long term. Obstructive sleep apnea (OSA) is a common clinical condition observed in patients with obesity. The primary aim of this protocol are to assess the inflammatory profile of severe obese patients undergone to bariatric surgery, through systemic and adipose markers of inflammation. A secondary objective is study the impact of this surgery on sleep variables and quality of life. Investigators hypothesized that weight loss induced by bariatric surgery reduces systemic inflammatory profile, improve sleep quality and quality of life of subjects with severe obesity. Will participate in this study, patients with severe obesity (BMI \> 40 or 35 to 39.9 kg/m2 associated comorbidities), with indication of bariatric surgery, screened Bariatric Surgery Service of Santa Casa de São Paulo in São Paulo. Inclusion criteria are severely obese, bariatric surgery indication and agreement to participate in the study. Are excluded patients with BMI \> 55 kg/m2, clinical instability, mental instability or significant and unrealistic expectations of surgery. Patients will be assessed before and after bariatric surgery, 90, 180 and 360 days. The evaluation protocol will consist of clinical history, vital signs, neck and waist circumference, clinical analysis of blood inflammatory markers, lung function tests, maximal ventilatory pressures, full overnight standard polysomnography, excessive daytime sleepiness scale, cardiovascular risk, quality of life and personal satisfaction questionnaires.

Detailed description: Obesity is a major public health problem in developed and developing countries, causing a range of respiratory and metabolic changes. There is a strong correlation between obesity and cardiorespiratory sleep disorders. The weight loss reduces the comorbidities and improves the quality of life, but clinical treatment it is not effective for a long period. In this context, currently bariatric surgery is an option for the real weight loss in the long term. Obstructive sleep apnea (OSA) is a common clinical condition observed in patients with obesity. Recent studies have found that more than 2/3 of obese patients also have OSA, and that these exhibit similar pathophysiological substrates for cardiovascular disease where increased blood pressure is a common consequence. This raises another discussion where obesity and OSA may have an additive effect on cardiovascular risk factors. Our main objective is to evaluate whether the systemic and adipose markers of inflammation alters after bariatric surgery through biochemical indexes in the visceral (omental, mesenteric) and subcutaneous adipose tissue depots and fasting blood samples, including the proinflammatory cytokines tumor necrosis factor α (TNFα), interleukin 6 (IL-6), interleukin 8 (IL-8), interleukin 18 (IL-18), soluble TNF receptor-2 (sTNFR2), soluble E-selectin, soluble intercellular adhesion molecule-1 (sICAM-1), soluble vascular cell adhesion molecule-1 (sVCAM-1), monocyte chemoattractant protein 1 (MCP 1), high sensitivity C-reactive protein (hsCRP), adiponectin (AdipoQ) genes, vascular endothelial growth factor A (VEGF-A), nuclear factor Kappa B (NF-kB) and adipose-derived hormone leptin. Moreover, identify the possible association of systemic and adipose inflammation before bariatric surgery with the magnitude of surgery-induced weight loss and to assess pulmonary function through spirometry and, maximal ventilatory pressures through vacuometry; to determine whether surgical procedure induced decrease in body weight, BMI, abdominal circumference and, improve quality of life; to study sleep patterns through full standard polysomnography and quality of life in obese patients undergone to bariatric surgery and verify a possible correlation between weight loss and physiological variables. Will participate in this study, patients with severe obesity (BMI \> 40 or 35 to 39.9 kg/m2 associated comorbidities), with indication of bariatric surgery, screened Bariatric Surgery Service of Santa Casa de São Paulo in São Paulo. Inclusion criteria are severely obese, bariatric surgery indication and agreement to participate in the study. Are excluded patients with BMI \> 55 kg/m2, clinical instability, mental instability or significant and unrealistic expectations of surgery. Patients will be assessed before and after bariatric surgery, 90, 180 and 360 days. The evaluation protocol will consist of clinical history, vital signs, neck and waist circumference, clinical analysis of blood inflammatory markers, lung function tests, maximal ventilatory pressures, full overnight standard polysomnography, excessive daytime sleepiness scale, cardiovascular risk, quality of life and personal satisfaction questionnaires.

Eligibility criteria: Inclusion Criteria:

1. Patients eligible for the trial must comply with all of the following at randomization:
2. male and female patients aged 18 to 65 years,
3. grade III severe obesity (BMI ≥ 40 kg/m2) or ≥ 35 kg/m2 with comorbidities,
4. awaiting bariatric surgery,
5. with documented history of conventional weight loss attempts having proven unsuccessful over time,
6. and if they are able to understand and agreement to participate in the study through a signed term of informed consent.

Exclusion Criteria:

1. Any medical condition rendering surgery too risky;
2. BMI above 55 kg/m2;
3. Unrealistic postoperative target weight and/or unrealistic expectations of surgical treatment;
4. Pregnancy, lactation or planned pregnancy within two years of potential surgical treatment;
5. Lack of safe access to abdominal cavity or gastrointestinal tract;
6. Abusive alcohol use or drug use.
7. Cancer
8. Any cardiorespiratory condition opposite indicate the surgical procedure.

Primary outcomes:
measure: Change in systemic immune response after bariatric surgery.
timeFrame: Baseline immune response to 180 days.
measure: Change in systemic adipose inflammation response after bariatric surgery.
timeFrame: Baseline adipose inflammation response to 180 days.
Secondary outcomes:
measure: Alterations in sleep quality after bariatric surgery.
timeFrame: 180 days
measure: Changes in pulmonary function after bariatric surgery.
timeFrame: 180 days
measure: Changes in maximal ventilatory pressures after bariatric surgery.
timeFrame: 180 days
measure: Changes in health related quality of life after bariatric surgery.
timeFrame: 180 days
Other outcomes:
Locations:
city: Anápolis
country: Brazil
facility: Gastromed
state: GO
city: Anápolis
country: Brazil
facility: Centro Universitário de Anápolis - UniEVANGÉLICA
state: GO
city: Sao Paulo
country: Brazil
facility: Department of Surgery of Santa Casa of São Paulo Medical School, Gastric Surgery Division
state: SP
Study officials:
References:
citation: de Sousa ART, Freitas Junior WR, Perez EA, Ilias EJ, Silva AS, Alves VLS, Afonso JPR, Oliveira MC, Fonseca AL, da Silva MM, Lino MEM, Oliveira Junior MC, Vieira RP, Pedro WJS, Bachi ALL, Insalaco G, Malheiros CA, Oliveira LVF. Surgery for Obesity and Weight-Related Diseases Changes the Inflammatory Profile in Women with Severe Obesity: a Randomized Controlled Clinical Trial. Obes Surg. 2021 Dec;31(12):5224-5236. doi: 10.1007/s11695-021-05702-5. Epub 2021 Sep 23.
citation: Perez EA, Oliveira LVF, Freitas WR Jr, Malheiros CA, Ilias EJ, Silva AS, Urbano JJ, Oliveira PC, Cepeda FX, Sampaio LMM, Trombetta IC, Delle H, Neto DG, Nacif SR, Stirbulov R. Prevalence and severity of syndrome Z in women with metabolic syndrome on waiting list for bariatric surgery: a cross-sectional study. Diabetol Metab Syndr. 2017 Sep 20;9:72. doi: 10.1186/s13098-017-0269-2. eCollection 2017.