Clinical trial NCT03115502: Hemodynamic Changes and Vascular Tone Control After Bariatric Surgery
Official title: Hemodynamic Changes and Vascular Tone Control After Bariatric Surgery. Prognostic Value Regarding Hypertension and Target Organ Damage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Vascular Resistance
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean changes 24h-aortic systolic-blood pressure (SBP) measured in mmHg
timeFrame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
Secondary outcomes:
measure: Mean changes in aortic- 24h, daytime and nighttime blood pressure estimates others than 24h systolic blood pressure measured in mmHg
timeFrame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
measure: Mean changes in peripheral- 24h, daytime and nighttime blood pressure estimates measured in mmHg
timeFrame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
measure: Mean change in office blood pressure estimates measured in mmHg
timeFrame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
measure: Mean change in arterial stiffness parameters (I)
timeFrame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
measure: Mean change in arterial stiffness parameters (II)
timeFrame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
measure: Mean change in Left ventricular mass index
timeFrame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
measure: Mean change in Left atrium diameter
timeFrame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
measure: Mean change in Ejection fraction
timeFrame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
measure: Mean change in left ventricular remodeling index
timeFrame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
measure: Mean change in carotid intima-media thickness measured in mm
timeFrame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
measure: Mean change in biochemical parameters measured in mg/dl or mmol/L
timeFrame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
measure: Mean change in the components of the renin-angiotensin system
timeFrame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
measure: Mean change in the serotonergic system components
timeFrame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
measure: Mean change in the components of the endocannabinoid system
timeFrame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
measure: Mean change in pro-atherosclerotic markers
timeFrame: From baseline to the final exam (12 months) with intermediate evaluations at 1, 3 and 6 months.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar_Nefrology
Study officials:
References:
citation: 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.
citation: 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.