Sleep and Immune Response in Severe Obese Patients Undergoing Bariatric Surgery.

Sponsor

Centro Universitário de Anapolis (Other)

Overall Status

Unknown status

CT.gov ID

NCT02409160

Collaborator

Irmandade da Santa Casa de Misericordia de Sao Paulo (Other), Clínica de Gastroenterologia e Medicina Avançada - GASTROMED (Other), Santa Casa de Misericórdia de Anápolis (Other)

Enrollment

Locations

Arms

Duration (Months)

5.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Severe Obesity Morbid Obesity	Procedure: Standard Roux-en-Y gastric bypass	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Mar 1, 2015

Anticipated Primary Completion Date :

Jul 1, 2018

Anticipated Study Completion Date :

Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bariatric Surgery Standard laparoscopic Roux-en-Y gastric bypass technique resulting in a gastric pouch with a volume of about 25 mL, a 100-cm-long Roux-limb, and a 75-cm-long biliopancreatic limb.	Procedure: Standard Roux-en-Y gastric bypass
No Intervention: Control Group

Arm

Intervention/Treatment

Experimental: Bariatric Surgery

Standard laparoscopic Roux-en-Y gastric bypass technique resulting in a gastric pouch with a volume of about 25 mL, a 100-cm-long Roux-limb, and a 75-cm-long biliopancreatic limb.

Procedure: Standard Roux-en-Y gastric bypass

No Intervention: Control Group

Outcome Measures

Primary Outcome Measures

Change in systemic immune response after bariatric surgery. [Baseline immune response to 180 days.]
Systemic markers of inflammation through fasting blood samples biochemical indexes.
Change in systemic adipose inflammation response after bariatric surgery. [Baseline adipose inflammation response to 180 days.]
Systemic markers of inflammation through biochemical indexes in the visceral (omental, mesenteric) and subcutaneous adipose tissue depots.

Secondary Outcome Measures

Alterations in sleep quality after bariatric surgery. [180 days]
Study sleep patterns through full standard polysomnography.
Changes in pulmonary function after bariatric surgery. [180 days]
Assess pulmonary function through spirometry.
Changes in maximal ventilatory pressures after bariatric surgery. [180 days]
Assess maximal inspiratory and expiratory pressures through vacuometry.
Changes in health related quality of life after bariatric surgery. [180 days]
Changes in quality of life through Short Form-36 and BAROS questionnaires.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients eligible for the trial must comply with all of the following at randomization:
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,
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.
Cancer
Any cardiorespiratory condition opposite indicate the surgical procedure.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gastromed	Anápolis	GO	Brazil	75080730
2	Centro Universitário de Anápolis - UniEVANGÉLICA	Anápolis	GO	Brazil	75083-515
3	Department of Surgery of Santa Casa of São Paulo Medical School, Gastric Surgery Division	Sao Paulo	SP	Brazil	01221-0100