Hemodynamic Changes and Vascular Tone Control After Bariatric Surgery

Completed

• Conditions: Systemic Vascular Resistance

• Registration Number: NCT03115502
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2016-01-13
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-14
• Primary Completion: 2018-12
• Study Completion: 2019-04
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-04
• Last Update Posted: 2020-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.	pulse wave velocity measured in m/s
Mean change in Left atrium diameter	From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.	Left atrium diameter measured in mm
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.	left ventricular remodeling index, do not have units
Mean change in the serotonergic system components	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
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 index	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
Mean change in Ejection fraction	From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.	Ejection fraction measured in %,
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.	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 components of the endocannabinoid system	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
Mean change in pro-atherosclerotic markers	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

Trial Locations

Locations (1)

Hospital del Mar_Nefrology; 🇪🇸 Barcelona, Spain