Evaluation of Endothelial and Vascular Functions in Obese Patients (FUENVASOB)

NCT05778513 | Completed

• 1 other identifier: 01C122
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; Endothelial function; Vascular function; Passive leg movements

Outcome Measures

Primary Outcomes (2)

• Change from baseline in blood flow in the femoral artery in Cases

  Change from baseline in blood flow in the femoral artery to Passive knee flexion-extension + Cycle ergometer exercise

  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 in Controls

  Change from baseline in blood flow in the femoral artery to Passive knee flexion-extension + Cycle ergometer exercise

  At baseline and at end of test

Secondary Outcomes (2)

• 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

Study Arms (2)

Cases

Male subjects with obesity

Other: Passive knee flexion-extension + Cycle ergometer exercise + 3-week body weight reduction program

Controls

Male subjects without obesity

Other: Passive knee flexion-extension + Cycle ergometer exercise

Interventions

Passive knee flexion-extension + Cycle ergometer exercise + 3-week body weight reduction program OTHER

Passive knee flexion-extension movements + Incremental cycle ergometer exercise + Multidisciplinary body weight reduction program with a duration of 3 weeks

Cases

Passive knee flexion-extension + Cycle ergometer exercise OTHER

Passive knee flexion-extension movements + Incremental cycle ergometer exercise

Controls

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: male
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Male obese subjects (BMI \> 97th percentile for age and gender (minors) and \>35 (adults), hospitalized for a multisciplinary integrated 3 week body weight reduction program

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano, Site Piancavallo

Oggebbio, Verbania, 28824, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum samples

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 21, 2023
• Study Start: August 31, 2021
• Primary Completion: April 14, 2022
• Study Completion: April 14, 2022
• Last Updated: March 21, 2023

Record last verified: 2023-03

Locations

IT (1)