Evaluation of Systemic Microvascular Endothelial Function in Metabolically Healthy Obesity

Obesity Clinical Trial

Official title:

Evaluation of Systemic Microvascular Endothelial Function in Metabolically Healthy Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04233528
• Other study ID #: CAAE 13959019.0.0000.5272
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: January 2023
• Source: National Institute of Cardiology, Laranjeiras, Brazil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 30, 2022
• Est. primary completion date: December 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemias
• Obesity
• Obesity, Metabolically Benign

Intervention

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.

Locations

Country	Name	City	State
Brazil	National Institute of Cardiology	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cardiology, Laranjeiras, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.