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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Bárbara Dal Molin Netto, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT02101814
First received: March 26, 2014
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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
Obesity
Morbid Obesity
Metabolic Syndrome
Inflammation
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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 24 months [ Time Frame: 24 months ] [ Designated as safety issue: No ]

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)

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02101814

Locations
Brazil
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
Investigators
Study Director: Ana R Dâmaso, PhD Federal University of Sao Paulo
  More Information

Additional Information:
No publications provided

Responsible Party: Bárbara Dal Molin Netto, Energy balance and inflammatory parameters after RYGB, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02101814     History of Changes
Other Study ID Numbers: BNetto
Study First Received: March 26, 2014
Last Updated: April 11, 2014
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Metabolic Syndrome X
Inflammation
Obesity
Obesity, Morbid
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014