In this study the effects of a two-week moderately intense-intense physical activity on vascular function, glucose-metabolism, lipid-metabolism and adipose tissue function will be analyzed.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in FMD measurement results between the exercise group and control
group directly before and after the walking-route. (ΔFMD-ΔFMD)
Secondary outcome
1. Differences in EndoPAT measurement results between the exercise group and
control group directly before and after the walking-route. (ΔEndoPAT-ΔEndoPAT)
2. Differences in PWV measurement results between the exercise group and
control group directly before and after the walking-route. (ΔPWV-ΔPWV)
3. Differences in insulin resistance, glucose concentrations, lipid
concentrations and adipokine concentrations between the exercise group and
control group directly before and after the walking-route
Background summary
Rationale:
A sedentary lifestyle has been linked to increased cardiovascular morbidity and
mortality. A trend towards decreased physical activity in the past decades has
led to an increased prevalence of obesity and obesity-related complications
such as cardiovascular disease, diabetes and cancer. It has been shown in
different populations that exercise training programs lead to an improvement of
the cardiovascular risk profile by enhancing insulin sensitivity, altering the
lipid profile and reducing blood pressure. Endothelial dysfunction appears
early in the process of atherosclerosis and has been associated with
cardiovascular disease. Endothelial function may improve after intervening in
cardiovascular risk factors. Likewise, exercise has been shown to improve
endothelial function in several previous studies.
In this study the effects of a two-week moderately intense-intense physical
activity on vascular function, glucose-metabolism, lipid-metabolism and adipose
tissue function will be analyzed in healthy participants of a Santiago
pilgrimage compared to controls.
Study objective
In this study the effects of a two-week moderately intense-intense physical
activity on vascular function, glucose-metabolism, lipid-metabolism and adipose
tissue function will be analyzed.
Study design
Observational cohort study, with a control group.
Study burden and risks
The Santiago-study is an observational study. Non-invasive techniques will be
used to assess endothelial function, vascular stiffness, central blood pressure
and heart rate variability.
Invasive procedures are limited to vena punctures and finger pricks to obtain
blood samples (total amount of ± 85 ml of blood during the study per study
subject).
4 Visits at the study site will be planned, which will last for approximately
1.5 hours each.
Heidelberglaan 100
3584 CX
Nederland
Heidelberglaan 100
3584 CX
Nederland
Listed location countries
Age
Inclusion criteria
Inclusion criteria
1. Male or female subjects, 40-70 years of age
2. Voluntary participation in the Santiago de Compostela pilgrimage (only applicable for the exercise group)
3. Written and signed informed consent
Exclusion criteria
1. A history of diabetes mellitus or use of glucose-lowering medication
2. A recent history (within the last year) of alcohol or drug abuse or dependence
3. Changes in blood pressure lowering medication in the previous month and/or insufficiently controlled hypertension (systolic blood pressure >170 mmHg)
4. Usage of any lipid-lowering medication
5. A history of mental instability or major psychiatric illness not adequately controlled and stable on pharmacotherapy
6. A current (advanced) malignancy and/or current treatment for malignancy
7. A history of significant aortic coarctation
8. Significant deformity of fingers of either hand prohibiting use of the same digit on both hands for EndoPAT-measurement
9. A history of upper extremity thrombosis
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL26889.041.09 |