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

Obesity Clinical Trial

Official title:

Analysis of Neuroendocrine Regulation of Balance Energy and Inflammatory Factors in Obese Adults Submitted to Bariatric Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02101814
• Other study ID #: BNetto
• Status: Active, not recruiting
• Phase: N/A
• First received: March 26, 2014
• Last updated: April 11, 2014
• Start date: March 2013

Study information

• Verified date: April 2014
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 41
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Energy Balance
• Inflammation
• Metabolic Syndrome
• Metabolic Syndrome X
• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

Procedure:
• Roux-en-Y gastric bypass (bariatric surgery)

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas/Federal University of Paraná	Curitiba	Paraná

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 6 months		6 months	No
Secondary	Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 24 months		24 months	No

External Links

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