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Clinical Trials/NCT04233528
NCT04233528
Completed
Not Applicable

Evaluation of Systemic Microvascular Endothelial Function in Metabolically Healthy Obesity

National Institute of Cardiology, Laranjeiras, Brazil1 site in 1 country112 target enrollmentJune 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
National Institute of Cardiology, Laranjeiras, Brazil
Enrollment
112
Locations
1
Primary Endpoint
Baseline and post-iontophoresis of acetylcholine endothelium-dependent skin microvascular reactivity
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2019
End Date
December 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National Institute of Cardiology, Laranjeiras, Brazil
Responsible Party
Principal Investigator
Principal Investigator

Eduardo Tibirica, MD, PhD

Senior Researcher

National Institute of Cardiology, Laranjeiras, Brazil

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.

Outcomes

Primary Outcomes

Baseline and post-iontophoresis of acetylcholine endothelium-dependent skin microvascular reactivity

Time Frame: Microvascular reactivity will be evaluated after a 20-minute rest in the supine position in a temperature-controlled room.

Evaluation of systemic microvascular reactivity induced by endothelium-dependent agents. Microvascular reactivity will be evaluated using a non-invasive and operator -independent methodology, named laser speckle contrast imaging, coupled with skin iontophoresis of vasodilator agents. Cutaneous microvascular flow will be measured in arbitrary perfusion units, divided by mean arterial pressure, to yield cutaneous vascular conductance.

Study Sites (1)

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