To evaluate the effect of a LiPA intervention on arterial stiffness in individuals with T2D.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is pulse-wave velocity and carotid distensibility which
will be determined with the use of applanation tonometry and arterial
ultrasound. The effect of the intervention on the primary outcome PWV at month
6 will be analysed.
Secondary outcome
Secondary outcomes include the amount of physical activity and sedentary
behaviour, metabolic risk factors (fasting glucose, fasting insulin, HbA1c,
lipid profile, creatinine, albumin and biomarkers of endothelial dysfunction
(vWF, s-VCAM-1, sE-selectin, sTM, SICAM-1) and low-grade inflammation(CRP, SAA,
IL-6, TNF-alfa, IL-8) and blood pressure); body composition (weight, fat mass);
quality of life; and depressive symptoms.
Background summary
In type 2 diabetes (T2D), physical activity is an important modifiable risk
factor of cardiovascular disease (CVD) and increased physical activity has been
shown to positively impact cardiovascular health. Unfortunately (long-term)
compliance to exercise programs in patients with T2D is poor. Light-intensity
physical activity ((LiPA); i.e., walking slowly, household activities or taking
a flight of stairs) is also associated with a decreased CVD risk and can be
more easily incorporated into daily life.
Study objective
To evaluate the effect of a LiPA intervention on arterial stiffness in
individuals with T2D.
Study design
This study is a single-blinded randomized controlled trial. The duration of the
study is 12 months; a 6-month intervention with a 6 month follow-up period.
Intervention
The intervention group will receive 4 workshops focussing on strategies to
increase LiPA by reducing sedentary time. Participants in the intervention
group will receive a feedback physical activity monitor worn on the wrist, data
will be synchronized with a mobile phone app. The activity monitor will give
real-time feedback on activity levels and will be used to set activity goals.
Participants in the intervention group are encouraged to decrease their
sedentary time with 10%. Participant in the control group will also receive 4
workshops focused on healthy lifestyle and do not receive an activity monitor.
Study burden and risks
Study measurements of all participants will take place at baseline, month 3,
month 6, and month 12 at the Maastricht UMC+. For the LiPA intervention only
non-invasive low risk study procedures will be performed and the risk for any
adverse events due to the different study procedures low. The burden of the
intervention for participants is low since LiPA can be easily incorporated in
daily life.
P. Debyelaan 25 P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25 P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
- 40-70 years old
- having type 2 diabetes
- BMI 20-35 kg/m2
- having a sedentary lifestyle (i.e., self-reported moderate-to-vigorous
physical activity < 150 minutes per week)
- willingness to undergo randomization
- being in the possession of personally owned smart phone
Exclusion criteria
- not being able to walk for 15 minutes for any (medical) reason
- currently engaged in an (medical) exercise program
- plan to move out of the study area in the next 12 months
- (digital) illiteracy or being unable to read Dutch
- a history of any cardiovascular event (including stroke) three months prior
to possible inclusion
- a history of signs or symptoms of ischemic heart disease and(or) heart
failure three months prior to possible inclusion
- a history or signs or symptoms of peripheral arterial disease three months
prior to possible inclusion
- a history or signs or symptoms of severe diabetic neuropathy or diabetic foot
ulcers three months prior to possible inclusion
- a history of sign or symptoms of severe diabetic retinopathy three months
prior to possible inclusion
- a history or sign or symptoms of severe osteoarthritis or severe joint
complaints three months prior to possible inclusion
- a history or signs or symptoms of COPD (eligible are those participants with
a COPD Gold classification <= I)
- uncontrolled diabetes (i.e., uncontrolled hypo- or hyperglycaemia)
- uncontrolled hypertension (i.e., systolic / diastolic blood pressure >= 180 /
95 mmHg)
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 | NL57173.068.16 |