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Clinical Trials/NCT03115502
NCT03115502CompletedNot Applicable

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

Parc de Salut Mar1 site in 1 country50 target enrollmentStarted: August 2013Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Mean changes 24h-aortic systolic-blood pressure (SBP) measured in mmHg
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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

  • Mean changes in peripheral- 24h, daytime and nighttime blood pressure estimates measured in mmHg(From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.)
  • Mean change in arterial stiffness parameters (I)(From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.)
  • Mean change in Left atrium diameter(From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.)
  • Mean changes in aortic- 24h, daytime and nighttime blood pressure estimates others than 24h systolic blood pressure measured in mmHg(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(From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.)
  • Mean change in left ventricular remodeling index(From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.)
  • Mean change in the serotonergic system components(From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.)
  • Mean change in arterial stiffness parameters (II)(From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.)
  • Mean change in Left ventricular mass index(From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.)
  • Mean change in Ejection fraction(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(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(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(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(From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.)
  • Mean change in pro-atherosclerotic markers(From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.)

Investigators

Sponsor
Parc de Salut Mar
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Anna Oliveras

Head of Hypertension & Vascular Risk Unit. Nephrology Department

Parc de Salut Mar

Study Sites (1)

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