Energy Balance and Inflammation in Obese Adults Bariatric Surgery Follow-up
Primary Purpose
Obesity, Morbid Obesity, Metabolic Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Roux-en-Y gastric bypass (bariatric surgery)
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
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
Sites / Locations
- Hospital de Clínicas/Federal University of Paraná
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Bariatric surgery
Arm Description
Roux-en-Y gastric bypass procedure is being performed by surgery in all patients in this study.
Outcomes
Primary Outcome Measures
Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 6 months
Secondary Outcome Measures
Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 24 months
Full Information
NCT ID
NCT02101814
First Posted
March 26, 2014
Last Updated
April 11, 2014
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02101814
Brief Title
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
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid Obesity, Metabolic Syndrome, Inflammation, Energy Balance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bariatric surgery
Arm Type
Other
Arm Description
Roux-en-Y gastric bypass procedure is being performed by surgery in all patients in this study.
Intervention Type
Procedure
Intervention Name(s)
Roux-en-Y gastric bypass (bariatric surgery)
Primary Outcome Measure Information:
Title
Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 24 months
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana R Dâmaso, PhD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Clínicas/Federal University of Paraná
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80060-900
Country
Brazil
12. IPD Sharing Statement
Links:
URL
http://asmbs.org/
Description
Related Info
URL
http://www.sbcb.org.br/
Description
Related Info
Learn more about this trial
Energy Balance and Inflammation in Obese Adults Bariatric Surgery Follow-up
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