Clinical Trials Directory

Trials / Completed

CompletedNCT04233528

Evaluation of Systemic Microvascular Endothelial Function in Metabolically Healthy Obesity

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
112 (actual)
Sponsor
National Institute of Cardiology, Laranjeiras, Brazil · Other Government
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Accepted

Summary

Obesity is known to be a risk factor for cardiovascular disease (CVD), type 2 diabetes mellitus, gastrointestinal tract disease, respiratory problems (such as obstructive sleep apnea), joint and muscle problems, reproductive disorders, depression and cancer. However, recently a new classification has emerged about obesity, the metabolically healthy obesity (MHO). According to the definition of the term, MHO represents obesity that occurs segregated from the metabolic syndrome criteria defined by the International Diabetes Federation (IDF). However, as there is still disagreement about the definition of MHO, the cardiovascular risk of these individuals is also uncertain. This phenotype may present as an intermediate risk between metabolically healthy normal-weight individuals and metabolically unhealthy obese individuals (MUO) or as a transition stage of the disease; when evolving to MUO, represents a higher risk of developing CVDs. The hypothesis of the present study is that obese individuals classified as metabolically healthy have worse vascular endothelial function when compared to non-obese individuals, demonstrating increased cardiovascular risk even in this subgroup considered "low risk". The detection of endothelial dysfunction in metabolically healthy obese may help in the prevention, treatment and follow-up of these individuals, aiming to reduce the development and morbidity and mortality of CVD. In the present study, the investigators will use a laser-based method for evaluating non-invasive, operator-independent systemic microvascular function that detects microvascular flow in the skin for the evaluation of systemic vascular endothelial function.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTEvaluation of systemic skin microvascular endothelial functionLaser-based method for evaluating non-invasive, operator-independent systemic microvascular function that detects microvascular flow in the skin for the evaluation of systemic vascular endothelial function.

Timeline

Start date
2019-06-01
Primary completion
2022-12-10
Completion
2022-12-30
First posted
2020-01-18
Last updated
2023-01-18

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT04233528. Inclusion in this directory is not an endorsement.