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

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 Overview

• Status: Completed
• Conditions: Systemic Vascular Resistance

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar_Nefrology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18 - 65 years, who have medical indication for treatment with bariatric surgery and agreeing to undergo the intervention.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Parc de Salut Mar

Publications and helpful links

General Publications

• Oliveras A, Molina L, Goday A, Sans L, Riera M, Vazquez S, Benaiges D, Granados AM, Ramon JM, Pascual J. Effect of bariatric surgery on cardiac structure and function in obese patients: Role of the renin-angiotensin system. J Clin Hypertens (Greenwich). 2021 Jan;23(1):181-192. doi: 10.1111/jch.14129. Epub 2020 Dec 17.
• Oliveras A, Goday A, Sans L, Arias CE, Vazquez S, Benaiges D, Ramon JM, Pascual J. Changes in Central 24-h Ambulatory Blood Pressure and Hemodynamics 12 Months After Bariatric Surgery: the BARIHTA Study. Obes Surg. 2020 Jan;30(1):195-205. doi: 10.1007/s11695-019-04107-9.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (ACTUAL): December 1, 2018
• Study Completion (ACTUAL): April 1, 2019

Study Registration Dates

• First Submitted: January 13, 2016
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (ACTUAL): April 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 5, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Baritha

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO