Severe ObesityNCT02409160
Sleep and Immune Response in Severe Obese Patients Undergoing Bariatric Surgery.
A study testing Standard Roux-en-Y gastric bypass in people with Severe Obesity and Morbid Obesity, run by Centro Universitário de Anapolis at 3 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severe Obesity, Morbid Obesity
- What is being tested?
- Standard Roux-en-Y gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesBrazil
- Study dates
- Mar 2015to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites, 3 recruiting
- Recruiting
Gastromed
Anápolis, Goiás, 75080730
Wilson JS Pedro, MD, +55 62 30998304, wilsonpedrosena@yahoo.com.br
Wilson JS Pedro, MD
- Recruiting
Centro Universitário de Anápolis - UniEVANGÉLICA
Anápolis, Goiás, 75083-515
Luis VF Oliveira, PhD, +55 62 33106600 ext. 6717, oliveira.lvf@gmail.com
- Recruiting
Department of Surgery of Santa Casa of São Paulo Medical School, Gastric Surgery Division
São Paulo, São Paulo, 01221-0100
Carlos A Malheiros, PhD, +55 11 2176-7689 ext. 7688, camalheiros@gmail.com
Wilson R Freitas Junior, MSc, +55 11 999144789, wrfjr@uol.com.br
About this study
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
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.
- Conditions
- Severe Obesity, Morbid Obesity
- Being tested
- Standard Roux-en-Y gastric bypass
- Keywords
- Severe Obesity, Sleep Disorders, Bariatric Surgery, Inflammation, Quality of Life
- Medical subject headings
- Obesity, Morbid, Sleep Wake Disorders, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Roux-en-Y gastric bypassProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Bariatric Surgery | Experimental | 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. Receives: Procedure: Standard Roux-en-Y gastric bypass |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systemic immune response after bariatric surgery.
Systemic markers of inflammation through fasting blood samples biochemical indexes.
Measured: Baseline immune response to 180 days.
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.
Measured: Baseline adipose inflammation response to 180 days.
Secondary outcomes (4)
Alterations in sleep quality after bariatric surgery.
Study sleep patterns through full standard polysomnography.
Measured: 180 days
Changes in pulmonary function after bariatric surgery.
Assess pulmonary function through spirometry.
Measured: 180 days
Changes in maximal ventilatory pressures after bariatric surgery.
Assess maximal inspiratory and expiratory pressures through vacuometry.
Measured: 180 days
Changes in health related quality of life after bariatric surgery.
Changes in quality of life through Short Form-36 and BAROS questionnaires.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2018 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Severe ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Universitário de Anapolis
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Luis Vicente Franco de Oliveira, Centro Universitário de Anapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409160
- Sponsor's protocol ID
- 220506/2009
- Status last verified
- May 2018
- First submitted
- 24 Mar 2015
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Felipe LA, Bachi ALL, Oliveira MC, Moreira SMBP, Afonso JPR, Lino MEM, Paixao V, Silva CHM, Vieira RP, Vencio S, Jirjos EI, Malheiros CA, Insalaco G, Junior WRF, Oliveira LVF. Effects of Roux-en-Y gastric bypass on the metabolic profile and systemic inflammatory status of women with metabolic syndrome: randomized controlled clinical trial. Diabetol Metab Syndr. 2023 Feb 14;15(1):19. doi: 10.1186/s13098-023-00986-2.
PubMed 36788619de 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 34554379Perez 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
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02409160
- Acronym / sponsor ID
- 220506/2009
- Conditions
- Severe Obesity, Morbid Obesity
- Keywords
- Severe Obesity, Sleep Disorders, Bariatric Surgery, Inflammation, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Centro Universitário de AnapolisUniversity, hospital or other
- Collaborators
- Irmandade da Santa Casa de Misericordia de Sao Paulo, Clínica de Gastroenterologia e Medicina Avançada - GASTROMED, Santa Casa de Misericórdia de Anápolis
- Study start
- Mar 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 6 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bariatric Surgery | Experimental | Procedure: Standard Roux-en-Y gastric bypassStandard 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. |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Roux-en-Y gastric bypass | Procedure or surgery | Bariatric Surgery |
Primary outcome
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.
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.
4 secondary outcomes
Alterations in sleep quality after bariatric surgery.
Time frame: 180 days
Changes in pulmonary function after bariatric surgery.
Time frame: 180 days
Changes in maximal ventilatory pressures after bariatric surgery.
Time frame: 180 days
Changes in health related quality of life after bariatric surgery.
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Derived from this study: PubMed 36788619Felipe LA, Bachi ALL, Oliveira MC, Moreira SMBP, Afonso JPR, Lino MEM, Paixao V, Silva CHM, Vieira RP, Vencio S, Jirjos EI, Malheiros CA, Insalaco G, Junior WRF, Oliveira LVF. Effects of Roux-en-Y gastric bypass on the metabolic profile and systemic inflammatory status of women with metabolic syndrome: randomized controlled clinical trial. Diabetol Metab Syndr. 2023 Feb 14;15(1):19. doi: 10.1186/s13098-023-00986-2.
- Derived from this study: PubMed 34554379de 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.
- Derived from this study: PubMed 28943894Perez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Roux-en-Y gastric bypass in people with Severe Obesity and Morbid Obesity, run by Centro Universitário de Anapolis at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis VF Oliveira, PhD (+55 11 991702292, oliveira.lvf@pq.cnpq.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systemic immune response after bariatric surgery. (time frame: Baseline immune response to 180 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02409160, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2018.