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Completed

NCT Number: NCT03115502

Hemodynamic Changes and Vascular Tone Control After Bariatric Surgery

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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Key information

Conditions

Systemic Vascular Resistance

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital del Mar_Nefrology

Barcelona, 08003, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unmeeting the above Inclusion Criteria.

Treatment and study plan

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)

    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

  5. 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 %

  6. 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

  7. 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

  8. 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 %,

  9. 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

  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

    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

  13. 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

  14. 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

  15. 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

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2019
First posted
Apr 14, 2017
Registry last updated
Mar 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.