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

May 3, 2018 updated by: Luis Vicente Franco de Oliveira, Centro Universitário de Anapolis

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • GO
      • Anápolis, GO, Brazil, 75083-515
        • Recruiting
        • Centro Universitário de Anápolis - UniEVANGÉLICA
        • Contact:
      • Anápolis, GO, Brazil, 75080730
        • Recruiting
        • Gastromed
        • Contact:
        • Principal Investigator:
          • Wilson JS Pedro, MD
    • SP
      • Sao Paulo, SP, Brazil, 01221-0100
        • Recruiting
        • Department of Surgery of Santa Casa of São Paulo Medical School, Gastric Surgery Division
        • Contact:
        • Contact:
          • Wilson R Freitas Junior, MSc
          • Phone Number: +55 11 999144789
          • Email: wrfjr@uol.com.br

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in systemic immune response after bariatric surgery.
Time Frame: 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 after bariatric surgery.
Time Frame: Baseline adipose inflammation response to 180 days.
Systemic markers of inflammation through biochemical indexes in the visceral (omental, mesenteric) and subcutaneous adipose tissue depots.
Baseline adipose inflammation response to 180 days.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Universitário de Anapolis

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

March 24, 2015

First Submitted That Met QC Criteria

April 3, 2015

First Posted (Estimate)

April 6, 2015

Study Record Updates

Last Update Posted (Actual)

May 9, 2018

Last Update Submitted That Met QC Criteria

May 3, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 220506/2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Morbid Obesity

Clinical Trials on Standard Roux-en-Y gastric bypass

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe