Energy Balance and Inflammation in Obese Adults Bariatric Surgery Follow-up

Federal University of São Paulo

Status: Unknown

Conditions: Inflammation; Obesity; Morbid Obesity; Energy Balance; Metabolic Syndrome

Treatments: Procedure: Roux-en-Y gastric bypass (bariatric surgery)

Study type: Interventional

Funder types: Other

Identifiers

NCT02101814

BNetto

Details and patient eligibility

About

The prevalence of obesity is steadily growing in many parts of the world in order to reach epidemic proportions. Changes in signaling pathways state of hunger and satiety contribute to the increase in obesity and metabolic syndrome. Currently, the white adipose tissue, also is considered a secretory tissue by producing numerous adipokines involved in a chronic state of inflammation, which may interfere with the neuroendocrine regulation of energy balance that affect the weight loss process. The bariatric surgery is recommended as the most effective tool in the treatment and control of morbid obesity. The study population will consist of patients undergoing bariatric surgery of type Roux-en-Y gastric bypass. The study was performed in Clinical Hospital of the Federal University of Paraná (UFPR). This is a prospective cohort study with follow up of 6 and 24 months. The aim of this study is to assess the effects of weight loss after bariatric surgery associated anthropometric characteristic, metabolic changes (glucose, cholesterol profile,hepatic enzymes, Fibroblast growth factor- 21(FGF-21), blood pressure), the profile of adipokines pro/anti-inflammatory (adiponectin, interleukin-6 (IL-6),interleukin-10 (IL-10), C reactive protein (CRP), plasminogen activator inhibitor-1 (PAI-1), tumor necrosis factor alpha (TNF-α), intercellular adhesion molecule-1 (ICAM-1), resistin, frizzled-related protein 5 (SFrp5) and neuroendocrine regulation of energy balance (leptin, neuropeptide Y (NPY) , alpha-melanocyte stimulating hormone (α-MSH), melanin-concentrating hormone (MCH) and agouti-related peptide (AgRP), as well as the quality of life in obese adults.

Enrollment: 41 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age range 20-59 years
• BMI ≥ 40 kg/m2
• BMI ≥ 35 kg/m2 with comorbidity recognised by National Institutes of Health.

Exclusion criteria

• Patients in use of insulin
• Patients in use of Immunosuppressant
• Anti-inflammatory and/or immunosuppressant therapies
• Any malignancy
• Chronic kidney or liver disease
• Obesity caused by an endocrine disorder
• Patients with psychiatric disorders
• Smoker or alcohol dependence
• Patients with rheumatoid arthritis and/or autoimmune

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Bariatric surgery

Other group

Description:

Roux-en-Y gastric bypass procedure is being performed by surgery in all patients in this study.

Treatment:

Procedure: Roux-en-Y gastric bypass (bariatric surgery)