Hemodynamic Changes and Vascular Tone Control After Bariatric Surgery

March 4, 2020 updated by: Anna Oliveras, Parc de Salut Mar

Hemodynamic Changes and Vascular Tone Control After Bariatric Surgery. Prognostic Value Regarding Hypertension and Target Organ Damage

Obese patients have increased cardiovascular risk and target organ damage (TOD) as compared to people with normal weight. Weight loss reduces cardiovascular risk and TOD. These changes have been associated mainly to changes in inflammatory and pro-atherogenic markers. Office peripheral blood pressure (BP) appears to decrease after bariatric surgery, but information on changes in 24h-ambulatory-BP-monitoring (24h-ABPM) and central-BP(cBP), or about the possible role of renin-angiotensin-aldosterone (RAAS), serotonin(STS) and endocannabinoid(ECS) systems is scarce. Our hypothesis is that the hemodynamic changes mediated by alterations in the RAAS, STS and ECS after weight loss are also responsible for the reduction of TOD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar_Nefrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients aged 18 - 65 years, who have medical indication for treatment with bariatric surgery and agreeing to undergo the intervention.

Description

Inclusion Criteria:

  1. Patients aged 18 - 65 years,
  2. who have medical indication for treatment with bariatric surgery and agreeing to undergo the intervention,with
  3. given informed consent

Exclusion Criteria:

1. Unmeeting the above Inclusion Criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Mean changes 24h-aortic systolic-blood pressure (SBP) measured in mmHg
Time Frame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean changes in aortic- 24h, daytime and nighttime blood pressure estimates others than 24h systolic blood pressure measured in mmHg
Time Frame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
Mean changes in peripheral- 24h, daytime and nighttime blood pressure estimates measured in mmHg
Time Frame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
Mean change in office blood pressure estimates measured in mmHg
Time Frame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
Mean change in arterial stiffness parameters (I)
Time Frame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
pulse wave velocity measured in m/s
From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
Mean change in arterial stiffness parameters (II)
Time Frame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
augmentation index measured in %
From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
Mean change in Left ventricular mass index
Time Frame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
Left ventricular mass index measured in g/m2
From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
Mean change in Left atrium diameter
Time Frame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
Left atrium diameter measured in mm
From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
Mean change in Ejection fraction
Time Frame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
Ejection fraction measured in %,
From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
Mean change in left ventricular remodeling index
Time Frame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
left ventricular remodeling index, do not have units
From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
Mean change in carotid intima-media thickness measured in mm
Time Frame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
Mean change in biochemical parameters measured in mg/dl or mmol/L
Time Frame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
Mean change in the components of the renin-angiotensin system
Time Frame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
renin-angiotensin system: plasma renin activity: ng/mL/h, plasma aldosterone: pg/ml, angiotensinogen: mng/100ml, angiotensin 1-7: pg/ml, ACE: UI/l, ACE-2: UI/I
From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
Mean change in the serotonergic system components
Time Frame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
serotonergic system: 5-HIAA:ng/ml, 5-HT:ng/mL
From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
Mean change in the components of the endocannabinoid system
Time Frame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
endocannabinoid system: Anandamide: nmol/mL, 2-arachidonoylglycerol: mg/ml
From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
Mean change in pro-atherosclerotic markers
Time Frame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
pro-atherosclerotic markers: omentine-1: ng/ml, chemerine: ng/ml, leptin: ng/ml, adiponectine: mcg/ml
From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Parc de Salut Mar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Baritha

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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