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

NCT02409160 | Unknown DMC

• 1 other identifier: 220506/2009
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

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.

Conditions

Severe Obesity; Morbid Obesity

Keywords

Severe Obesity; Sleep Disorders; Bariatric Surgery; Inflammation; Quality of Life

Outcome Measures

Primary Outcomes (2)

• Change in systemic immune response after bariatric surgery.

  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.

  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 Outcomes (4)

• Alterations in sleep quality after bariatric surgery.

  180 days

• Changes in pulmonary function after bariatric surgery.

  180 days

• Changes in maximal ventilatory pressures after bariatric surgery.

  180 days

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

  180 days

Study Arms (2)

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.

Procedure: Standard Roux-en-Y gastric bypass

Control Group

NO INTERVENTION

Interventions

Standard Roux-en-Y gastric bypass PROCEDURE

Bariatric Surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Universitário de Anapolis: lead
• Irmandade da Santa Casa de Misericordia de Sao Paulo: collaborator
• Clínica de Gastroenterologia e Medicina Avançada - GASTROMED: collaborator
• Santa Casa de Misericórdia de Anápolis: collaborator

Study Sites (3)

Gastromed

Anápolis, Goiás, 75080730, Brazil

RECRUITING

Centro Universitário de Anápolis - UniEVANGÉLICA

Anápolis, Goiás, 75083-515, Brazil

RECRUITING

Department of Surgery of Santa Casa of São Paulo Medical School, Gastric Surgery Division

São Paulo, São Paulo, 01221-0100, Brazil

RECRUITING

Related Publications (3)

• 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.

  PMID: 36788619 DERIVED

• 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.

  PMID: 34554379 DERIVED

• 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.

  PMID: 28943894 DERIVED

MeSH Terms

Conditions

Obesity, Morbid; Sleep Wake Disorders; Inflammation

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Neurologic Manifestations; Mental Disorders; Pathologic Processes

Central Study Contacts

Luis VF Oliveira, PhD

CONTACT

+55 11 991702292; oliveira.lvf@pq.cnpq.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: April 6, 2015
• Study Start: March 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2019
• Last Updated: May 9, 2018

Record last verified: 2018-05

Locations

BR (3)