Evaluation of Systemic Microvascular Endothelial Function in Metabolically Healthy Obesity

National Institute of Cardiology, Laranjeiras, Brazil

Status: Completed

Conditions: Dyslipidemias; Obesity

Treatments: Diagnostic Test: Evaluation of systemic skin microvascular endothelial function

Study type: Interventional

Funder types: Other

Identifiers

NCT04233528

CAAE 13959019.0.0000.5272

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• obese individuals (BMI ≥ 30.0 kg / m2) meeting the criteria for metabolically healthy obesity

Exclusion criteria

• Pregnancy or lactation.
• Endocrine disorders except diabetes, cardiovascular disease except systemic arterial hypertension, autoimmune diseases, malignant neoplasms.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 3 patient groups

healthy volunteers

Experimental group

Description:

metabolically healthy eutrophic individuals (BMI ≥18.5 and \<25 kg / m2) without any IDF criteria for metabolic syndrome

Treatment:

Diagnostic Test: Evaluation of systemic skin microvascular endothelial function

metabolically healthy obesity

Experimental group

Description:

obese individuals (BMI ≥ 30.0 kg / m2) meeting the criteria for metabolically healthy obesity

Treatment:

Diagnostic Test: Evaluation of systemic skin microvascular endothelial function

metabolically unhealthy obesity

Experimental group

Description:

volunteers diagnosed with metabolically unhealthy obesity

Treatment:

Diagnostic Test: Evaluation of systemic skin microvascular endothelial function