Biomarkers Derived From Adipose Tissue Useful for Diagnosis and Prognosis of Cardiovascular Risk (CVR) in Obese Patient

• Conditions: Diabetes Mellitus; Inflammatory Response; Metabolic Syndrome
• Interventions: Procedure: Bariatric surgery

• Registration Number: NCT03561987
• Lead Sponsor: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Brief Summary

This study evaluates the relationship between the adipose tissue, as an active component, which can define metabolic phenotypes linked to cardiovascular risk modification post bariatric surgery.

Detailed Description

Bariatric surgery induces a significant reduction in co-morbidities associated with obesity, such as Diabetes mellitus, dyslipidemia, liver disease, arterial hypertension, obstructive apnea and cardiovascular risk. However this does not happen in all obese patients, even when there is a weight reduction.

It is known that the adipose tissue is actively involved in synthesis of cytokines and its role in metabolic phenotypes has been suggested. It is possible that the intrinsic mechanisms of adipose tissue participate in several benefits observed in morbidly obese patients who undergo to an anti-obesity surgery.

So this study explores the involvement of adipose tissue as an active component, which can define metabolic phenotypes linked to cardiovascular risk modification post bariatric surgery.

Study Timeline

• Study Start: 2013-11-06
• Status Verified: 2018-06
• Study First Submitted: 2018-06-08
• Study First Submitted QC: 2018-06-08
• Study First Posted: 2018-06-19
• Last Update Submitted: 2018-07-03
• Last Update Posted: 2018-07-05
• Primary Completion: 2020-12-01
• Study Completion: 2022-01-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Above 18 years old.
• Morbid obese patients candidates to bariatric surgery.

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Exclusion Criteria

• Second bariatric surgery

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No obese patients and abdominal surgery	Bariatric surgery	The investigators include men and women, over 18 years old, without obesity and candidates for abdominal surgery (hernioplasty, cholecystectomy, fundoplication), under the routine of the treating service, with signature of acceptance of your participation, by informed consent. The investigators exclude patients with medication with potential effect on adipose tissue or cardiovascular risk in the last month, also with severe infections in the last month or clinically unstable conditions. Patients are eliminated in the study if they dont have the desire to continue in the study, and if the samples or the information are insufficient for an adequate analysis.
Obese patients and bariatric surgery	Bariatric surgery	The investigators include men and women, over 18 years old, with morbid obesity and candidates for bariatric surgery, under the routine of the treating service, with signature of acceptance of your participation, by informed consent. The investigators exclude patients with medication with potential effect on adipose tissue or cardiovascular risk in the last month, also with severe infections in the last month or clinically unstable conditions. Patients are eliminated in the study if they dont have the desire to continue in the study, and if the samples or the information are insufficient for an adequate analysis.

Primary Outcome Measures

Name	Time	Method
Evaluate the association of the cardiovascular benefit of the obese patient after bariatric surgery with the basic mechanisms of adipose tissue (metabolic profile)	3 years	Evaluate the association of the cardiovascular benefit of the obese patient after bariatric surgery with the basic mechanisms of adipose tissue (metabolic profile)

Secondary Outcome Measures

Name	Time	Method
Correlation between serum concentration of pro-inflammatory biomarker and the reduction of subclinical endothelial disfunction.	9 months	measurements of carotid intima-media thickness (CIMT) in millimeter and Flow mediated dilatation (FMD) in percent in a basal time and see over time the reduction (if any) of those endothelial markers
Determine the association of the cardiovascular prognosis modification (risk subgroups) with the basal metabolic profile.	9 months	After the 9 months follow up, the authors will correlated the pro-inflammatory cytokines, presence or absence of adipose proteins.