Hemodynamic Changes and Vascular Tone Control After Bariatric Surgery

• Sponsor: Parc de Salut Mar (Other)
• Overall Status: Completed
• CT.gov ID: NCT03115502
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Duration (Months): 68
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Systemic Vascular Resistance

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Hemodynamic Changes and Vascular Tone Control After Bariatric Surgery. Prognostic Value Regarding Hypertension and Target Organ Damage
• Study Start Date: Aug 1, 2013
• Actual Primary Completion Date: Dec 1, 2018
• Actual Study Completion Date: Apr 1, 2019

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.]

2. 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.]

3. 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.]

4. 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

5. 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 %

6. 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

7. 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

8. 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 %,

9. 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

10. 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.]

11. 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.]

12. 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

13. 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

14. 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

15. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital del Mar_Nefrology	Barcelona		Spain	08003

Sponsors and Collaborators

• Parc de Salut Mar

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anna Oliveras, Head of Hypertension & Vascular Risk Unit. Nephrology Department, Parc de Salut Mar
• ClinicalTrials.gov Identifier: NCT03115502
• Other Study ID Numbers: Baritha
• First Posted: Apr 14, 2017
• Last Update Posted: Mar 5, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

No Results Posted as of Mar 5, 2020