Energy Balance and Inflammation in Obese Adults Bariatric Surgery Follow-up
This trial is active, not recruiting.
|Conditions||obesity, morbid obesity, metabolic syndrome, inflammation, energy balance|
|Treatment||roux-en-y gastric bypass (bariatric surgery)|
|Sponsor||Federal University of São Paulo|
|Collaborator||Fundação de Amparo à Pesquisa do Estado de São Paulo|
|Start date||March 2013|
|End date||May 2015|
|Trial size||41 participants|
|Trial identifier||NCT02101814, BNetto|
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.
|Intervention model||single group assignment|
Roux-en-Y gastric bypass procedure is being performed by surgery in all patients in this study.
Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 6 months
time frame: 6 months
Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 24 months
time frame: 24 months
Male or female participants from 20 years up to 60 years old.
- Age range 20-59 years
- BMI ≥ 40 kg/m2
- BMI ≥ 35 kg/m2 with comorbidity recognised by National Institutes of Health.
- 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
|Official title||Analysis of Neuroendocrine Regulation of Balance Energy and Inflammatory Factors in Obese Adults Submitted to Bariatric Surgery|
Call for more information