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

NCT ID: NCT02101814

Last Updated: 2014-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Brief Summary

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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

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Conditions

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Obesity Morbid Obesity Metabolic Syndrome Inflammation Energy Balance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bariatric surgery

Roux-en-Y gastric bypass procedure is being performed by surgery in all patients in this study.

Group Type OTHER

Roux-en-Y gastric bypass (bariatric surgery)

Intervention Type PROCEDURE

Interventions

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Roux-en-Y gastric bypass (bariatric surgery)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Bárbara Dal Molin Netto

Energy balance and inflammatory parameters after RYGB

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ana R Dâmaso, PhD

Role: STUDY_DIRECTOR

Federal University of São Paulo

Locations

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Hospital de Clínicas/Federal University of Paraná

Curitiba, Paraná, Brazil

Site Status

Countries

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Brazil

Related Links

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Other Identifiers

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BNetto

Identifier Type: -

Identifier Source: org_study_id

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