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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Roux-en-Y gastric bypass procedure is being performed by surgery in all patients in this study.
roux-en-y gastric bypass (bariatric surgery)

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
time frame: 24 months

Eligibility Criteria

Male or female participants from 20 years up to 60 years old.

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

Additional Information

Official title Analysis of Neuroendocrine Regulation of Balance Energy and Inflammatory Factors in Obese Adults Submitted to Bariatric Surgery
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Federal University of São Paulo.