Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05778513 |
| Other study ID # |
01C122 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 31, 2021 |
| Est. completion date |
April 14, 2022 |
Study information
| Verified date |
March 2023 |
| Source |
Istituto Auxologico Italiano |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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:
1. BMI > 97th percentile for age and gender (minors) and >35 (adults).
2. not having done structured physical activity programs (regular activity for more than
120 min/week) during the 6 months preceding the study.
3. absence of pathologies such as diabetes or insulin resistance.
4. 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.
The anthropometric characteristics and body composition of the patients will be determined by
tetrapolar impedance analysis (Human-IM Scan, DS-Medigroup, Milan, Italy).
Experimental protocols The tests will be conducted under strict medical supervision,
following standard safety protocols. The proposed measures are non-invasive, with the
exception of venous blood sampling.
At the beginning and at the end of the standard period of stay of the patient at the Hospital
(hospitalization/rehabilitation period lasting 3 weeks, including a combined intervention of
aerobic physical activity, caloric restriction and psychological counseling), each subject
will undergo, on two different days, to the following protocols:
1. On the first day, the blood flow in the common femoral artery will be determined
continuously, by Echo-Doppler method (duplex mode) during passive knee flexion-extension
movements (passive leg movement, PLM). To perform this measurement, the subject will
assume a sitting position on a special seat. After adequate familiarization, the subject
will perform two repetitions, lasting about one minute each, separated by a few minutes
of intervals, of a series of passive movements (limb guided by an operator) of flexion
and extension of a lower limb (width of movement 90°; knee angle 180°-90°-180°), with a
frequency of 1 Hz. During passive movements, the blood flow in the common femoral artery
will be determined by Echo-Doppler (duplex mode). The blood flow will be calculated,
according to standardized procedures and with the synchronization with the ECG tracing,
based on the measured values of femoral artery diameter (B-mode) and blood flow velocity
(pulse-vawe mode). The data obtained during the two repetitions of the experiment will
be superimposed on each other for analysis. From the tracing of the blood flow as a
function of time, the following evaluation parameters of the peripheral
vascular-microvascular function will be calculated: blood flow peak; difference between
peak flow and resting flow; area under the blood flow versus time curve.
2. On the second day, the patient will perform incremental cycle ergometer exercise (3
minutes rest, 20 watts for 2 minutes and then 20 watt/min increments) conducted until
voluntary exhaustion, for determination of "peak" O2 consumption (V̇O2 peak) and of the
"ventilatory thresholds".
Lung ventilation, V̇O2 and carbon dioxide emission (V̇CO2) will be determined
breath-by-breath by CPX express metabolizer (Medical Graphics Corporation, St Paul, MN,
USA). Arterial oxygen saturation (SaO2) will be determined by earlobe pulse oximetry.
The heart rate (heart rate [HR]) will be determined on the basis of the
electrocardiographic (ECG) signal, while the arterial pressure will be determined by a
sphygmomanometer. The perception of fatigue will be determined using a Borg 6-20 scale.
3. Venous blood samples will be collected from the antecubital vein of the arm, before the
protocol described in point 1) and immediately after the incremental exercise described
in point 2). On the blood samples, evaluation variables of endothelial function and
inflammation markers will be determined.
A portion of the sample will be delivered, following specific protocols, to the Analysis
Laboratory of the Piancavallo Hospital, where the following variables will be determined:
Total and HDL cholesterol, HOMA-IR (insulinemia, blood glucose), alpha-1 glycoprotein, CRP,
IL-6, TNF-alpha, ICAM-1, VCAM-1, testosterone, cortisol, insulin, irisin, pancreatic peptide,
GH, plasma lactate; nitrites, nitrates, prostacyclin (6-keto), von Willebrand factor,
endothelin, hyaluronic acid, syndecan, heparan sulfate; Plasma and serum BDNF, plasma TrkB
receptor; BCAA (leucine, isoleucine, valine) and BCAA (3 hydroxy-isobutyrate) metabolites
(valine intermediate).
