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Systemic Vascular ResistanceNCT03115502

Hemodynamic Changes and Vascular Tone Control After Bariatric Surgery

An observational study of Systemic Vascular Resistance, run by Parc de Salut Mar at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Systemic Vascular Resistance
How many people
50 participants
Where
1 siteSpain
Study dates
Aug 2013to Apr 2019
Phase
Observational
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 1. Unmeeting the above Inclusion Criteria.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital del Mar_Nefrology

    Barcelona, 08003

Other trials in Spain

About this study

Official title: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean changes 24h-aortic systolic-blood pressure (SBP) measured in mmHg

    Measured: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.

Secondary outcomes (15)

  1. Mean changes in aortic- 24h, daytime and nighttime blood pressure estimates others than 24h systolic blood pressure measured in mmHg

    Measured: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.

  2. Mean changes in peripheral- 24h, daytime and nighttime blood pressure estimates measured in mmHg

    Measured: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.

  3. Mean change in office blood pressure estimates measured in mmHg

    Measured: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.

  4. Mean change in arterial stiffness parameters (I)

    pulse wave velocity measured in m/s

    Measured: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.

  5. Mean change in arterial stiffness parameters (II)

    augmentation index measured in %

    Measured: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.

  6. Mean change in Left ventricular mass index

    Left ventricular mass index measured in g/m2

    Measured: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.

  7. Mean change in Left atrium diameter

    Left atrium diameter measured in mm

    Measured: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.

  8. Mean change in Ejection fraction

    Ejection fraction measured in %,

    Measured: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.

  9. Mean change in left ventricular remodeling index

    left ventricular remodeling index, do not have units

    Measured: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.

  10. Mean change in carotid intima-media thickness measured in mm

    Measured: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.

  11. Mean change in biochemical parameters measured in mg/dl or mmol/L

    Measured: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.

  12. Mean change in the components of the renin-angiotensin system

    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

    Measured: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.

  13. Mean change in the serotonergic system components

    serotonergic system: 5-HIAA:ng/ml, 5-HT:ng/mL

    Measured: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.

  14. Mean change in the components of the endocannabinoid system

    endocannabinoid system: Anandamide: nmol/mL, 2-arachidonoylglycerol: mg/ml

    Measured: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.

  15. Mean change in pro-atherosclerotic markers

    pro-atherosclerotic markers: omentine-1: ng/ml, chemerine: ng/ml, leptin: ng/ml, adiponectine: mcg/ml

    Measured: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2017
  2. Study startAug 2013
  3. Primary completionDec 2018
  4. Study completionApr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03115502
Sponsor's protocol ID
Baritha
Status last verified
Mar 2020
First submitted
13 Jan 2016
Last updated
5 Mar 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Oliveras A, Molina L, Goday A, Sans L, Riera M, Vazquez S, Benaiges D, Granados AM, Ramon JM, Pascual J. Effect of bariatric surgery on cardiac structure and function in obese patients: Role of the renin-angiotensin system. J Clin Hypertens (Greenwich). 2021 Jan;23(1):181-192. doi: 10.1111/jch.14129. Epub 2020 Dec 17.

    PubMed 33331692

  • Oliveras A, Goday A, Sans L, Arias CE, Vazquez S, Benaiges D, Ramon JM, Pascual J. Changes in Central 24-h Ambulatory Blood Pressure and Hemodynamics 12 Months After Bariatric Surgery: the BARIHTA Study. Obes Surg. 2020 Jan;30(1):195-205. doi: 10.1007/s11695-019-04107-9.

    PubMed 31346932

Questions about this trial

What is this clinical trial studying?

An observational study of Systemic Vascular Resistance, run by Parc de Salut Mar at 1 site in Spain.

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 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 5 Mar 2020. 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 Spain. 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?

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?

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.). 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 NCT03115502, which also lists 2 linked publications.

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 5 Mar 2020.

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