ObesityNCT03911479
Evaluation of Heart Rate Variability and Endothelial Function Three Months After Bariatric Surgery
A study testing Bariatric Surgery in people with Obesity, run by Rio de Janeiro State University.
Trial summary
Was performed a longitudinal, study with twenty patients recruited for the bariatric surgery group and 20 for clinical treatment. The analysis of HRV and endothelial function were performed through peripheral arterial tonometry, in patients with obesity before and after three months of bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Bariatric Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 22 Feb 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with obesity grade 3 [Body Mass Index (BMI) ≥ 40kg/m2] or grade 2 (BMI 35-39.9kg/m2) with comorbidities
Who cannot join
- Current use of incretin mimetics or inhibitors of dipeptidyl peptidase-4 (DPP4); and history of a previous cardiovascular event (acute myocardial infarction, stroke or peripheral obstructive arterial disease)
About this study
Official title: Evaluation of Heart Rate Variability and Endothelial Function Three Months After Bariatric
Was performed a longitudinal, study with twenty patients recruited for the bariatric surgery group and 20 for clinical treatment. The analysis of HRV and endothelial function were performed through peripheral arterial tonometry, in patients with obesity before and after three months of bariatric surgery. Were also analyzed GLP-1, insulin and glucose at fast, and 30 and 60 minutes. The results were compared in parallel with a control group with clinical treatment for obesity.
Read the detailed description
To assess the pathophysiological mechanisms that leads the benefits in cardiovascular risk after bariatric surgery, through the autonomic nervous system and endothelial function, was performed a longitudinal, study with twenty patients recruited for the bariatric surgery group and 20 for clinical treatment.
The analysis of HRV and endothelial function were performed through peripheral arterial tonometry, in patients with obesity before and after three months of bariatric surgery.
Were also analyzed GLP-1, insulin and glucose at fast, and 30 and 60 minutes. The results were compared in parallel with a control group with clinical treatment for obesity.
- Conditions
- Obesity
- Being tested
- Bariatric Surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric SurgeryProcedure or surgery
Bariatric Surgery - convencionals Roux-en-Y gastric bypass (RYGB) and vertical gastrectomy (Sleeve; SG)
| Study group | Role | What they receive |
|---|---|---|
| Bariatric Surgery Group | Experimental | Not described Receives: Procedure: Bariatric Surgery |
| Clinical Threatment | Other | Convencional treatment in a public tertiary outpatients care unit Receives: Procedure: Bariatric Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate variability and endothelial function
assessed by peripheral arterial tonometry
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start1 Oct 2015
- Primary completion25 Feb 2016
- Study completion22 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Short-term, non-blinded, non-randomized longitudinal study comparing obese patients undergoing bariatric surgery with those on clinical treatment.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Collaborators
- Eliete Bouskela
- Responsible party
- Principal investigator, Luiz Guilherme Kraemer-Aguiar, MD, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911479
- Sponsor's protocol ID
- HRV_endo
- Status last verified
- Apr 2019
- First submitted
- 9 Apr 2019
- Last updated
- 11 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gomide Braga T, das Gracas Coelho de Souza M, Maranhao PA, Menezes M, Dellatorre-Teixeira L, Bouskela E, Le Roux CW, Kraemer-Aguiar LG. Evaluation of Heart Rate Variability and Endothelial Function 3 Months After Bariatric Surgery. Obes Surg. 2020 Jun;30(6):2450-2453. doi: 10.1007/s11695-020-04397-4.
PubMed 31916132
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Heart Rate Variability and Endothelial Function Three Months After Bariatric
- ClinicalTrials.gov ID
- NCT03911479
- Acronym / sponsor ID
- HRV_endo
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Collaborators
- Eliete Bouskela
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 25 Feb 2016 (actual)
- Study completion
- 22 Feb 2018 (actual)
- First posted
- 11 Apr 2019 (actual)
- 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.
Was performed a longitudinal, study with twenty patients recruited for the bariatric surgery group and 20 for clinical treatment. The analysis of HRV and endothelial function were performed through peripheral arterial tonometry, in patients with obesity before and after three months of bariatric surgery. Were also analyzed GLP-1, insulin and glucose at fast, and 30 and 60 minutes. The results were compared in parallel with a control group with clinical treatment for obesity.
Detailed description
To assess the pathophysiological mechanisms that leads the benefits in cardiovascular risk after bariatric surgery, through the autonomic nervous system and endothelial function, was performed a longitudinal, study with twenty patients recruited for the bariatric surgery group and 20 for clinical treatment.
The analysis of HRV and endothelial function were performed through peripheral arterial tonometry, in patients with obesity before and after three months of bariatric surgery.
Were also analyzed GLP-1, insulin and glucose at fast, and 30 and 60 minutes. The results were compared in parallel with a control group with clinical treatment for obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Short-term, non-blinded, non-randomized longitudinal study comparing obese patients undergoing bariatric surgery with those on clinical treatment.
| Arm | Type | Receives |
|---|---|---|
| Bariatric Surgery Group | Experimental | Procedure: Bariatric Surgery |
| Clinical Threatment | Other | Procedure: Bariatric SurgeryConvencional treatment in a public tertiary outpatients care unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with obesity grade 3 [Body Mass Index (BMI) ≥ 40kg/m2] or grade 2 (BMI 35-39.9kg/m2) with comorbidities
Key exclusion criteria (1 listed)
- Current use of incretin mimetics or inhibitors of dipeptidyl peptidase-4 (DPP4); and history of a previous cardiovascular event (acute myocardial infarction, stroke or peripheral obstructive arterial 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 |
|---|---|---|
| Bariatric SurgeryBariatric Surgery - convencionals Roux-en-Y gastric bypass (RYGB) and vertical gastrectomy (Sleeve; SG) | Procedure or surgery | Bariatric Surgery Group, Clinical Threatment |
Primary outcome
Rate variability and endothelial function
Time frame: 3 months
assessed by peripheral arterial tonometry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Derived from this study: PubMed 31916132Gomide Braga T, das Gracas Coelho de Souza M, Maranhao PA, Menezes M, Dellatorre-Teixeira L, Bouskela E, Le Roux CW, Kraemer-Aguiar LG. Evaluation of Heart Rate Variability and Endothelial Function 3 Months After Bariatric Surgery. Obes Surg. 2020 Jun;30(6):2450-2453. doi: 10.1007/s11695-020-04397-4.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric Surgery in people with Obesity, run by Rio de Janeiro State University.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate variability and endothelial function (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03911479, which also lists 1 linked publication.
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 11 Apr 2019.