Evaluation of Systemic Microvascular Endothelial Function in Metabolically Healthy Obesity

NCT04233528 | Completed

• 1 other identifier: CAAE 13959019.0.0000.5272
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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

Keywords

laser speckle contrast imaging

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

healthy volunteers

EXPERIMENTAL

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

metabolically healthy obesity

EXPERIMENTAL

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

Diagnostic Test: Evaluation of systemic skin microvascular endothelial function

metabolically unhealthy obesity

EXPERIMENTAL

volunteers diagnosed with metabolically unhealthy obesity

Diagnostic Test: Evaluation of systemic skin microvascular endothelial function

Interventions

Evaluation of systemic skin microvascular endothelial function 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.

healthy volunteers; metabolically healthy obesity; metabolically unhealthy obesity

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Institute of Cardiology, Laranjeiras, Brazil: lead

Study Sites (1)

National Institute of Cardiology

Rio de Janeiro, 21040-360, Brazil

Location

MeSH Terms

Conditions

Obesity; Dyslipidemias

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 18, 2020
• Study Start: June 1, 2019
• Primary Completion: December 10, 2022
• Study Completion: December 30, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)