Hemodynamic Changes and Vascular Tone Control After Bariatric Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Systemic Vascular Resistance

Participation Criteria
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Eligibility Criteria
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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: 1. Unmeeting the above Inclusion Criteria.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean changes 24h-aortic systolic-blood pressure (SBP) measured in mmHg |  | From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 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 arterial stiffness parameters (I) | pulse wave velocity measured in m/s | From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months. | 
| Mean change in arterial stiffness parameters (II) | augmentation index measured in % | From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months. | 
| Mean change in Left ventricular mass index | Left ventricular mass index measured in g/m2 | From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months. | 
| Mean change in Left atrium diameter | Left atrium diameter measured in mm | From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months. | 
| Mean change in Ejection fraction | Ejection fraction measured in %, | From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months. | 
| Mean change in left ventricular remodeling index | left ventricular remodeling index, do not have units | 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 | 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 | From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months. | 
| Mean change in the serotonergic system components | serotonergic system: 5-HIAA:ng/ml, 5-HT:ng/mL | 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 | endocannabinoid system: Anandamide: nmol/mL, 2-arachidonoylglycerol: mg/ml | From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months. | 
| Mean change in pro-atherosclerotic markers | pro-atherosclerotic markers: omentine-1: ng/ml, chemerine: ng/ml, leptin: ng/ml, adiponectine: mcg/ml | From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months. |