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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2014 by Bárbara Dal Molin Netto, Federal University of São Paulo.
Recruitment status was:  Active, not recruiting
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Bárbara Dal Molin Netto, Federal University of São Paulo Identifier:
First received: March 26, 2014
Last updated: April 11, 2014
Last verified: April 2014
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.

Condition Intervention
Morbid Obesity
Metabolic Syndrome
Energy Balance
Procedure: Roux-en-Y gastric bypass (bariatric surgery)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Analysis of Neuroendocrine Regulation of Balance Energy and Inflammatory Factors in Obese Adults Submitted to Bariatric Surgery

Resource links provided by NLM:

Further study details as provided by Bárbara Dal Molin Netto, Federal University of São Paulo:

Primary Outcome Measures:
  • Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 24 months [ Time Frame: 24 months ]

Estimated Enrollment: 41
Study Start Date: March 2013
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Bariatric surgery
Roux-en-Y gastric bypass procedure is being performed by surgery in all patients in this study.
Procedure: Roux-en-Y gastric bypass (bariatric surgery)


Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT02101814

Hospital de Clínicas/Federal University of Paraná
Curitiba, Paraná, Brazil, 80060-900
Sponsors and Collaborators
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Study Director: Ana R Dâmaso, PhD Federal University of Sao Paulo
  More Information

Additional Information:
Responsible Party: Bárbara Dal Molin Netto, Energy balance and inflammatory parameters after RYGB, Federal University of São Paulo Identifier: NCT02101814     History of Changes
Other Study ID Numbers: BNetto
Study First Received: March 26, 2014
Last Updated: April 11, 2014

Additional relevant MeSH terms:
Metabolic Syndrome X
Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases processed this record on May 25, 2017