Evaluation of Systemic Microvascular Endothelial Function in Metabolically Healthy Obesity

NCT ID: NCT04233528

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2022-12-30

Brief 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

Obesity; Dyslipidemias

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

healthy volunteers

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

Group Type: EXPERIMENTAL

Evaluation of systemic skin microvascular endothelial function

Intervention Type: DIAGNOSTIC_TEST

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.

metabolically healthy obesity

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

Group Type: EXPERIMENTAL

Evaluation of systemic skin microvascular endothelial function

Intervention Type: DIAGNOSTIC_TEST

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.

metabolically unhealthy obesity

volunteers diagnosed with metabolically unhealthy obesity

Group Type: EXPERIMENTAL

Evaluation of systemic skin microvascular endothelial function

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

Evaluation of systemic skin microvascular endothelial function

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Cardiology, Laranjeiras, Brazil

OTHER_GOV

Sponsor Role: lead

Responsible Party

Eduardo Tibirica, MD, PhD

Senior Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Institute of Cardiology

Rio de Janeiro, , Brazil

Countries

Brazil

Other Identifiers

CAAE 13959019.0.0000.5272

Identifier Type: -

Identifier Source: org_study_id