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Status unknownNCT02409160Updated May 9, 2018

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

An interventional study of Standard Roux-en-Y gastric bypass in Severe Obesity and Morbid Obesity, sponsored by Centro Universitário de Anapolis. Status unknown at 3 sites in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-05-09.

Sponsored by Centro Universitário de Anapolis · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Severe Obesity
  • Morbid Obesity

Keywords

  • Severe Obesity
  • Sleep Disorders
  • Bariatric Surgery
  • Inflammation
  • Quality of Life
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.

This study's planned enrollment of 17 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Centro Universitário de Anapolis is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
17 participants (estimated)

Study arms

  • 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

Interventions

  • ProcedureStandard Roux-en-Y gastric bypass
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What researchers measure

Primary outcomes

  1. Change in systemic immune response after bariatric surgery.

    Systemic markers of inflammation through fasting blood samples biochemical indexes.

    Time frame: Baseline immune response to 180 days.

  2. Change in systemic adipose inflammation response after bariatric surgery.

    Systemic markers of inflammation through biochemical indexes in the visceral (omental, mesenteric) and subcutaneous adipose tissue depots.

    Time frame: Baseline adipose inflammation response to 180 days.

Secondary outcomes

  1. Alterations in sleep quality after bariatric surgery.

    Study sleep patterns through full standard polysomnography.

    Time frame: 180 days

  2. Changes in pulmonary function after bariatric surgery.

    Assess pulmonary function through spirometry.

    Time frame: 180 days

  3. Changes in maximal ventilatory pressures after bariatric surgery.

    Assess maximal inspiratory and expiratory pressures through vacuometry.

    Time frame: 180 days

  4. Changes in health related quality of life after bariatric surgery.

    Changes in quality of life through Short Form-36 and BAROS questionnaires.

    Time frame: 180 days

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Study locations

3 of 3 sites recruiting
  • Gastromed
    Anápolis, GO 75080730, Brazil
    Recruiting
  • Centro Universitário de Anápolis - UniEVANGÉLICA
    Anápolis, GO 75083-515, Brazil
    Recruiting
  • Department of Surgery of Santa Casa of São Paulo Medical School, Gastric Surgery Division
    Sao Paulo, SP 01221-0100, Brazil
    Recruiting
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References and documents

Publications

  • 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. PubMed 34554379 ↗
  • 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. PubMed 28943894 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02409160
Lead 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
Responsible party
Luis Vicente Franco de Oliveira (Professor, Centro Universitário de Anapolis) — Principal investigator
First posted
Apr 6, 2015
Start date
Mar 2015
Primary completion
Jul 2018 (estimated)
Completion
Jul 2019 (estimated)
Last update
May 9, 2018

Study contacts

Luis VF Oliveira, PhD
Contact
oliveira.lvf@pq.cnpq.br
+55 11 991702292

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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