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

Study Overview
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Brief Summary
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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.

Official Title
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Analysis of Neuroendocrine Regulation of Balance Energy and Inflammatory Factors in Obese Adults Submitted to Bariatric Surgery

Conditions
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Obesity, Morbid Obesity, Metabolic Syndrome, Inflammation, Energy Balance

Intervention / Treatment
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* Procedure: Roux-en-Y gastric bypass (bariatric surgery)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Bariatric surgery<br>Roux-en-Y gastric bypass procedure is being performed by surgery in all patients in this study. | Procedure: Roux-en-Y gastric bypass (bariatric surgery)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 24 months |  | 24 months |