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Hemodynamic Changes and Vascular Tone Control After Bariatric Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03115502
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
Anna Oliveras, Parc de Salut Mar

Brief 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.

Condition or disease
Systemic Vascular Resistance

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hemodynamic Changes and Vascular Tone Control After Bariatric Surgery. Prognostic Value Regarding Hypertension and Target Organ Damage
Study Start Date : August 2013
Actual Primary Completion Date : December 2018
Actual Study Completion Date : April 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115502


Locations
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Spain
Hospital del Mar_Nefrology
Barcelona, Spain, 08003
Sponsors and Collaborators
Parc de Salut Mar
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anna Oliveras, Head of Hypertension & Vascular Risk Unit. Nephrology Department, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT03115502    
Other Study ID Numbers: Baritha
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No