NCT02101814

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Last Updated

April 14, 2014

Status Verified

April 1, 2014

Enrollment Period

2.2 years

First QC Date

March 26, 2014

Last Update Submit

April 11, 2014

Conditions

ObesityMorbid ObesityMetabolic SyndromeInflammationEnergy Balance

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 6 months

    6 months

Secondary Outcomes (1)

  • Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 24 months

    24 months

Study Arms (1)

Bariatric surgery

OTHER

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)

Interventions

Roux-en-Y gastric bypass (bariatric surgery)PROCEDURE
Bariatric surgery

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age range 20-59 years
  • BMI ≥ 40 kg/m2
  • BMI ≥ 35 kg/m2 with comorbidity recognised by National Institutes of Health.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas/Federal University of Paraná

Curitiba, Paraná, 80060-900, Brazil

Location

Related Links

MeSH Terms

Conditions

ObesityObesity, MorbidMetabolic SyndromeInflammation

Interventions

Gastric BypassBariatric Surgery

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesPathologic Processes

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Ana R Dâmaso, PhD

    Federal University of São Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Energy balance and inflammatory parameters after RYGB

Study Record Dates

First Submitted

March 26, 2014

First Posted

April 2, 2014

Study Start

March 1, 2013

Primary Completion

May 1, 2015

Last Updated

April 14, 2014

Record last verified: 2014-04

Locations

BR(1)