Clinical trial NCT02101814: Energy Balance and Inflammation in Obese Adults Bariatric Surgery Follow-up
Official title: Analysis of Neuroendocrine Regulation of Balance Energy and Inflammatory Factors in Obese Adults Submitted to Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Morbid Obesity
Metabolic Syndrome
Inflammation
Energy Balance
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2014-04-02
Enrollment: 41
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 24 months
timeFrame: 24 months
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Hospital de Clínicas/Federal University of Paraná
state: Paraná
Study officials:
affiliation: Federal University of São Paulo
name: Ana R Dâmaso, PhD
role: STUDY_DIRECTOR
References: