Evaluation of Systemic Microvascular Endothelial Function in Metabolically Healthy Obesity

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Dyslipidemias
• Intervention / Treatment: Diagnostic test: Evaluation of systemic skin microvascular endothelial function

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 21040-360
    • National Institute of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: healthy volunteers; metabolically healthy eutrophic individuals (BMI ≥18.5 and <25 kg / m2) without any IDF criteria for metabolic syndrome	Diagnostic test: 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.
Experimental: metabolically healthy obesity; obese individuals (BMI ≥ 30.0 kg / m2) meeting the criteria for metabolically healthy obesity	Diagnostic test: 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.
Experimental: metabolically unhealthy obesity; volunteers diagnosed with metabolically unhealthy obesity	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline and post-iontophoresis of acetylcholine endothelium-dependent skin microvascular reactivity	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.	Microvascular reactivity will be evaluated after a 20-minute rest in the supine position in a temperature-controlled room.

Collaborators and Investigators

• Sponsor: National Institute of Cardiology, Laranjeiras, Brazil

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): December 10, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: laser speckle contrast imaging
• Additional Relevant MeSH Terms: Metabolic Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Lipid Metabolism Disorders; Obesity; Dyslipidemias; Obesity, Metabolically Benign
• Other Study ID Numbers: CAAE 13959019.0.0000.5272

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No