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

Not Applicable

• Conditions: Energy Balance; Obesity; Metabolic Syndrome; Inflammation; Morbid Obesity
• Interventions: Procedure: Roux-en-Y gastric bypass (bariatric surgery)

• Registration Number: NCT02101814
• Lead Sponsor: Federal University of São Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-03-26
• Study First Submitted QC: 2014-03-30
• Status Verified: 2014-04
• Study First Posted: 2014-04-02
• Last Update Submitted: 2014-04-11
• Last Update Posted: 2014-04-14
• Primary Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bariatric surgery	Roux-en-Y gastric bypass (bariatric surgery)	Roux-en-Y gastric bypass procedure is being performed by surgery in all patients in this study.

Primary Outcome Measures

Name	Time	Method
Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 6 months	6 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 24 months	24 months

Trial Locations

Locations (1)

Hospital de Clínicas/Federal University of Paraná; 🇧🇷 Curitiba, Paraná, Brazil