Energy Balance and Inflammation in Obese Adults Bariatric... | NCT02101814

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

NCT02101814

Sponsor

Federal University of São Paulo

Status

Unknown status

Last Update Posted

Apr 14, 2014Estimated

Enrollment

41Estimated

Phase

Not Applicable

Conditions

Obesity
Morbid Obesity
Metabolic Syndrome
Inflammation
Energy Balance

Interventions

Roux-en-Y gastric bypass (bariatric surgery)

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

May 2015Estimated

Completion Date

Not provided

First Submitted Date

Mar 26, 2014

First Submission Date that Met QC Criteria

Mar 30, 2014

First Posted Date

Apr 2, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2014

Last Update Posted Date

Apr 14, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bárbara Dal Molin Netto, Energy balance and inflammatory parameters after RYGB, Federal University of São PauloPrincipal Investigator

Lead Sponsor

Federal University of São PauloOTHER

Collaborators

Name	Class
Fundação de Amparo à Pesquisa do Estado de São Paulo	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Roux-en-Y gastric bypass (bariatric surgery)	Procedure		Bariatric surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 6 months		6 months

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 24 months		24 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ana R Dâmaso, PhD	Federal University of São Paulo	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Clínicas/Federal University of Paraná		Curitiba	Paraná	80060-900	Brazil

Label	URL
Related Info	View source
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D009767	Obesity, Morbid
D024821	Metabolic Syndrome
D007249	Inflammation

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015390	Gastric Bypass
D050110	Bariatric Surgery

Ancestor Terms

ID	Term
D049088	Bariatrics
D000073319	Obesity Management
D013812	Therapeutics
D005763	Gastroenterostomy

Browse Leaves

Not provided

Browse Branches

Not provided