Analysis of Neuroendocrine Regulation of Balance Energy and Inflammatory Factors in Obese Adults Submitted to Bariatric Surgery
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 41
- Locations
- 2
- Primary Endpoint
- Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 6 months
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 6 months
Time Frame: 6 months
Secondary Outcomes
- Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 24 months(24 months)
Investigators
Bárbara Dal Molin Netto
Energy balance and inflammatory parameters after RYGB
Federal University of São Paulo