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

Diabetes Mellitus Clinical Trial

— CROP  

Official title:

Identification of Biomarkers Derived From Adipose Tissue With Potential Utility in the Diagnosis and Prognosis of Cardiovascular Risk of the Obese Patient.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03561987
• Other study ID #: 386.2013
• Status: Enrolling by invitation
• Start date: November 6, 2013
• Est. completion date: January 15, 2022

Study information

• Verified date: June 2018
• Source: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 70
• Est. completion date: January 15, 2022
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Above 18 years old.

• Morbid obese patients candidates to bariatric surgery.

Exclusion Criteria:

• Second bariatric surgery

Related Conditions & MeSH terms

• Diabetes Mellitus
• Inflammatory Response
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the association of the cardiovascular benefit of the obese patient after bariatric surgery with the basic mechanisms of adipose tissue (metabolic profile)	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
Secondary	Correlation between serum concentration of pro-inflammatory biomarker and the reduction of subclinical endothelial disfunction.	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	9 months
Secondary	Determine the association of the cardiovascular prognosis modification (risk subgroups) with the basal metabolic profile.	After the 9 months follow up, the authors will correlated the pro-inflammatory cytokines, presence or absence of adipose proteins.	9 months