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

NCT ID: NCT03561987

Last Updated: 2018-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-06
• Study Completion Date: 2022-01-15

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.

Conditions

Metabolic Syndrome; Diabetes Mellitus; Inflammatory Response

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Obese patients and 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.

Bariatric surgery

Intervention Type: PROCEDURE

There are two components to the procedure. First, a small stomach pouch, approximately one ounce or 30 milliliters in volume, is created by dividing the top of the stomach from the rest of the stomach. Next, the first portion of the small intestine is divided, and the bottom end of the divided small intestine is brought up and connected to the newly created small stomach pouch. The procedure is completed by connecting the top portion of the divided small intestine to the small intestine further down so that the stomach acids and digestive enzymes from the bypassed stomach and first portion of small intestine will eventually mix with the food.

No obese patients and abdominal 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.

Bariatric surgery

Intervention Type: PROCEDURE

There are two components to the procedure. First, a small stomach pouch, approximately one ounce or 30 milliliters in volume, is created by dividing the top of the stomach from the rest of the stomach. Next, the first portion of the small intestine is divided, and the bottom end of the divided small intestine is brought up and connected to the newly created small stomach pouch. The procedure is completed by connecting the top portion of the divided small intestine to the small intestine further down so that the stomach acids and digestive enzymes from the bypassed stomach and first portion of small intestine will eventually mix with the food.

Interventions

Bariatric surgery

There are two components to the procedure. First, a small stomach pouch, approximately one ounce or 30 milliliters in volume, is created by dividing the top of the stomach from the rest of the stomach. Next, the first portion of the small intestine is divided, and the bottom end of the divided small intestine is brought up and connected to the newly created small stomach pouch. The procedure is completed by connecting the top portion of the divided small intestine to the small intestine further down so that the stomach acids and digestive enzymes from the bypassed stomach and first portion of small intestine will eventually mix with the food.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Second bariatric surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

OTHER_GOV

Sponsor Role: lead

Responsible Party

Juan Antonio Suárez Cuenca

Ph.D. in Biomedical sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

386.2013

Identifier Type: -

Identifier Source: org_study_id