ight-intensity Physical Activity and Arterial Stiffness in Type 2 Diabetes
- Conditions
- diabeteshardening of the arteries10018424
- Registration Number
- NL-OMON55739
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 160
- 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
- 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is pulse-wave velocity and carotid distensibility which<br /><br>will be determined with the use of applanation tonometry and arterial<br /><br>ultrasound. The effect of the intervention on the primary outcome PWV at month<br /><br>6 will be analysed.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes include the amount of physical activity and sedentary<br /><br>behaviour, metabolic risk factors (fasting glucose, fasting insulin, HbA1c,<br /><br>lipid profile, creatinine, albumin and biomarkers of endothelial dysfunction<br /><br>(vWF, s-VCAM-1, sE-selectin, sTM, SICAM-1) and low-grade inflammation(CRP, SAA,<br /><br>IL-6, TNF-alfa, IL-8) and blood pressure); body composition (weight, fat mass);<br /><br>quality of life; and depressive symptoms.</p><br>