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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03561987
Acronym
CROP
Enrollment
70
Registered
2018-06-19
Start date
2013-11-06
Completion date
2022-01-15
Last updated
2018-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Inflammatory Response, Metabolic Syndrome

Keywords

ADIPOSE TISSUE, CARDIOVASCULAR, OBESE PATIENTS

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.

Interventions

PROCEDUREBariatric 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.

Sponsors

Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Second bariatric surgery

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the association of the cardiovascular benefit of the obese patient after bariatric surgery with the basic mechanisms of adipose tissue (metabolic profile)3 yearsEvaluate the association of the cardiovascular benefit of the obese patient after bariatric surgery with the basic mechanisms of adipose tissue (metabolic profile)

Secondary

MeasureTime frameDescription
Correlation between serum concentration of pro-inflammatory biomarker and the reduction of subclinical endothelial disfunction.9 monthsmeasurements 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 monthsAfter the 9 months follow up, the authors will correlated the pro-inflammatory cytokines, presence or absence of adipose proteins.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026