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Hemodynamic Changes and Vascular Tone Control After Bariatric Surgery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03115502
Enrollment
50
Registered
2017-04-14
Start date
2013-08-31
Completion date
2019-04-30
Last updated
2020-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Vascular Resistance

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.

Interventions

None listed

Sponsors

Parc de Salut Mar
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Mean changes 24h-aortic systolic-blood pressure (SBP) measured in mmHgFrom baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.

Secondary

MeasureTime frameDescription
Mean changes in peripheral- 24h, daytime and nighttime blood pressure estimates measured in mmHgFrom 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 mmHgFrom 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.pulse wave velocity measured in m/s
Mean change in arterial stiffness parameters (II)From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.augmentation index measured in %
Mean change in Left ventricular mass indexFrom baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.Left ventricular mass index measured in g/m2
Mean change in Left atrium diameterFrom baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.Left atrium diameter measured in mm
Mean change in Ejection fractionFrom baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.Ejection fraction measured in %,
Mean changes in aortic- 24h, daytime and nighttime blood pressure estimates others than 24h systolic blood pressure measured in mmHgFrom 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 mmFrom 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/LFrom 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 systemFrom 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
Mean change in the serotonergic system componentsFrom 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
Mean change in the components of the endocannabinoid systemFrom 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
Mean change in pro-atherosclerotic markersFrom 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
Mean change in left ventricular remodeling indexFrom baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.left ventricular remodeling index, do not have units

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026