ObesityNCT02101814
Energy Balance and Inflammation in Obese Adults Bariatric Surgery Follow-up
A study testing Roux-en-Y gastric bypass (bariatric surgery) in people with Obesity and Morbid Obesity, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Obesity, Morbid Obesity, Metabolic Syndrome
- What is being tested?
- Roux-en-Y gastric bypass (bariatric surgery)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2013to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age range 20-59 years
- BMI ≥ 40 kg/m2
- BMI ≥ 35 kg/m2 with comorbidity recognised by National Institutes of Health.
Who cannot join
- 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
Show all 9Show fewer
- Patients with psychiatric disorders
- Smoker or alcohol dependence
- Patients with rheumatoid arthritis and/or autoimmune
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas/Federal University of Paraná
Curitiba, Paraná, 80060-900
About this study
Official title: Analysis of Neuroendocrine Regulation of Balance Energy and Inflammatory Factors in Obese Adults Submitted to Bariatric Surgery
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.
- Conditions
- Obesity, Morbid Obesity, Metabolic Syndrome, Inflammation, Energy Balance
- Being tested
- Roux-en-Y gastric bypass (bariatric surgery)
- Medical subject headings
- Obesity, Obesity, Morbid, Metabolic Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y gastric bypass (bariatric surgery)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surgery | Other | Roux-en-Y gastric bypass procedure is being performed by surgery in all patients in this study. Receives: Procedure: Roux-en-Y gastric bypass (bariatric surgery) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 6 months
Measured: 6 months
Secondary outcomes (1)
Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 24 months
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startMar 2013
- Primary completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Bárbara Dal Molin Netto, Federal University of São Paulo
- Investigators
- Ana R Dâmaso, PhD, Study director, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101814
- Sponsor's protocol ID
- BNetto
- Status last verified
- Apr 2014
- First submitted
- 26 Mar 2014
- Last updated
- 14 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Neuroendocrine Regulation of Balance Energy and Inflammatory Factors in Obese Adults Submitted to Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02101814
- Acronym / sponsor ID
- BNetto
- Conditions
- Obesity, Morbid Obesity, Metabolic Syndrome, Inflammation, Energy Balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Mar 2013
- Primary completion
- May 2015 (estimated)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery | Other | Procedure: Roux-en-Y gastric bypass (bariatric surgery)Roux-en-Y gastric bypass procedure is being performed by surgery in all patients in this study. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age range 20-59 years
- BMI ≥ 40 kg/m2
- BMI ≥ 35 kg/m2 with comorbidity recognised by National Institutes of Health.
Key exclusion criteria (9 listed)
- Patients in use of insulin
- Patients in use of Immunosuppressant
- Anti-inflammatory and/or immunosuppressant therapies
- Any malignancy
- Chronic kidney or liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roux-en-Y gastric bypass (bariatric surgery) | Procedure or surgery | Bariatric surgery |
Primary outcome
Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 6 months
Time frame: 6 months
1 secondary outcome
Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 24 months
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2014.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana R Dâmaso, PhD study director
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roux-en-Y gastric bypass (bariatric surgery) in people with Obesity and Morbid Obesity, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in anthropometric, metabolic, energy balance parameters and inflammatory profile at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2014.