Evaluation of Endothelial and Vascular Functions in Obese Patients: Analysis of the Blood Flow in the Femoral Artery During Passive Movements of the Limbs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Istituto Auxologico Italiano
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Change from baseline in blood flow in the femoral artery in Cases
Study Overview
Brief Summary
The primary objective of the present study will be to evaluate, in obese patients, the blood flow response in the femoral artery in response to passive limb movements, taken as a biomarker of a possible limitation of the peripheral vascular-endothelial-microvascular function. The values will be compared with those obtained in normal subjects, in patients with cardiovascular (Gilford & Richardson 2017) or respiratory diseases (Ives et al. 2020), and in healthy subjects subjected to bed rest (Zuccarelli et al. 2020).
The data of the recruited obese patients will be obtained at the beginning and the end of the standard rehabilitation period (including calorie reduction interventions, physical exercise, and psychological counseling) conducted over 3 weeks at the Division of Auxology, Istituto Auxologico Italiano, Piancavallo, Italy. A secondary objective will be to evaluate any changes following the rehabilitation program on the patients' endothelial-peripheral-vascular-microvascular function. The data obtained will also be evaluated in comparison with hematochemical and molecular indices for evaluating the endothelial function, as well as with standard parameters for the overall functional evaluation of the oxidative function and the ability to sustain exercise ("peak" O2 consumption during exercise, thresholds anaerobic diseases.
Detailed Description
Materials and methods:
The study will be attended by 15 young obese males aged between 15 and 40 years recruited at the Division of Auxology (minors) and the Division of Metabolic Diseases (adults), Istituto Auxologico Italiano, IRCCS, Piancavallo, Italy.
The inclusion criteria for the study group will be:
- BMI > 97th percentile for age and gender (minors) and >35 (adults).
- not having done structured physical activity programs (regular activity for more than 120 min/week) during the 6 months preceding the study.
- absence of pathologies such as diabetes or insulin resistance.
- absence of signs/symptoms referable to cardiovascular, respiratory, gastrointestinal or musculoskeletal pathologies contraindicated for carrying out the tests.
Furthermore, 15 male control subjects of similar age, with normal BMI, will be recruited among friends and colleagues from the Department of Medical Area, University of Udine, who will have to satisfy the inclusion criteria 2-4 mentioned above.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 15 Years to 40 Years (Child, Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •BMI > 97th percentile for age and gender (minors) and >35 (adults).
- •not having done structured physical activity programs (regular activity for more than 120 min/week) during the 6 months preceding the study.
- •absence of pathologies such as diabetes or insulin resistance.
- •absence of signs/symptoms referable to cardiovascular, respiratory, gastrointestinal or musculoskeletal pathologies contraindicated for carrying out the tests.
Exclusion Criteria
- •having done structured physical activity programs (regular activity for more than 120 min/week) during the 6 months preceding the study
- •presence of diabetes or insulin resistance
- •presence of signs/symptoms referable to cardiovascular, respiratory, gastrointestinal or musculoskeletal pathologies contraindicated for carrying out the tests.
Outcomes
Primary Outcomes
Change from baseline in blood flow in the femoral artery in Cases
Time Frame: At baseline and at end of test, before and after 3 weeks of body weight reduction program
Change from baseline in blood flow in the femoral artery to Passive knee flexion-extension + Cycle ergometer exercise
Change from baseline in blood flow in the femoral artery in Controls
Time Frame: At baseline and at end of test
Change from baseline in blood flow in the femoral artery to Passive knee flexion-extension + Cycle ergometer exercise
Secondary Outcomes
- Evaluation of variables of endothelial function and inflammation markers - CRP(Baseline and after 3 weeks)
- Evaluation of variables of endothelial function and inflammation markers - IL-6(Baseline and after 3 weeks)