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CompletedNCT03115502Updated Mar 5, 2020

Hemodynamic Changes and Vascular Tone Control After Bariatric Surgery

An observational study in Systemic Vascular Resistance, sponsored by Parc de Salut Mar. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-03-05.

Sponsored by Parc de Salut Mar · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

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Conditions studied

  • Systemic Vascular Resistance
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In context

Lead sponsor

Parc de Salut Mar is the lead sponsor of 180 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  1. Unmeeting the above Inclusion Criteria.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Mean change in arterial stiffness parameters (I)

    pulse wave velocity measured in m/s

    Time frame: 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 %

    Time frame: 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

    Time frame: 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

    Time frame: 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 %,

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

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Study locations

1 site
  • Hospital del Mar_Nefrology
    Barcelona, 08003, Spain
08

References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03115502
Lead sponsor
Parc de Salut Mar
Responsible party
Anna Oliveras (Head of Hypertension & Vascular Risk Unit. Nephrology Department, Parc de Salut Mar) — Principal investigator
First posted
Apr 14, 2017
Start date
Aug 2013
Primary completion
Dec 2018
Completion
Apr 2019
Last update
Mar 5, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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