Hemodynamic Changes and Vascular Tone Control After Bariatric Surgery

Systemic Vascular Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03115502
• Other study ID #: Baritha
• Status: Completed
• Start date: August 2013
• Est. completion date: April 2019

Study information

• Verified date: March 2020
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Systemic Vascular Resistance

Locations

Country	Name	City	State
Spain	Hospital del Mar_Nefrology	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.