Evaluation of Systemic Microvascular Endothelial Function in Metabolically Healthy Obesity
Primary Purpose
Obesity, Dyslipidemias
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Evaluation of systemic skin microvascular endothelial function
Sponsored by
About this trial
This is an interventional screening trial for Obesity focused on measuring laser speckle contrast imaging
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.
Sites / Locations
- National Institute of Cardiology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
healthy volunteers
metabolically healthy obesity
metabolically unhealthy obesity
Arm Description
metabolically healthy eutrophic individuals (BMI ≥18.5 and <25 kg / m2) without any IDF criteria for metabolic syndrome
obese individuals (BMI ≥ 30.0 kg / m2) meeting the criteria for metabolically healthy obesity
volunteers diagnosed with metabolically unhealthy obesity
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04233528
First Posted
January 6, 2020
Last Updated
January 17, 2023
Sponsor
National Institute of Cardiology, Laranjeiras, Brazil
1. Study Identification
Unique Protocol Identification Number
NCT04233528
Brief Title
Evaluation of Systemic Microvascular Endothelial Function in Metabolically Healthy Obesity
Official Title
Evaluation of Systemic Microvascular Endothelial Function in Metabolically Healthy Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
December 10, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Cardiology, Laranjeiras, Brazil
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Dyslipidemias
Keywords
laser speckle contrast imaging
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
healthy volunteers
Arm Type
Experimental
Arm Description
metabolically healthy eutrophic individuals (BMI ≥18.5 and <25 kg / m2) without any IDF criteria for metabolic syndrome
Arm Title
metabolically healthy obesity
Arm Type
Experimental
Arm Description
obese individuals (BMI ≥ 30.0 kg / m2) meeting the criteria for metabolically healthy obesity
Arm Title
metabolically unhealthy obesity
Arm Type
Experimental
Arm Description
volunteers diagnosed with metabolically unhealthy obesity
Intervention Type
Diagnostic Test
Intervention Name(s)
Evaluation of systemic skin microvascular endothelial function
Intervention Description
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.
Primary Outcome Measure Information:
Title
Baseline and post-iontophoresis of acetylcholine endothelium-dependent skin microvascular reactivity
Description
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.
Time Frame
Microvascular reactivity will be evaluated after a 20-minute rest in the supine position in a temperature-controlled room.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
National Institute of Cardiology
City
Rio de Janeiro
ZIP/Postal Code
21040-360
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Systemic Microvascular Endothelial Function in Metabolically Healthy Obesity
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