Light-intensity Physical Activity and Arterial Stiffness in Type 2 Diabetes

Light-intensity Physical Activity and Arterial Stiffness in Type 2 Diabetes - LiPAT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55739

Enrollment

160

Registered

2016-12-22

Start date

2018-11-08

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes hardening of the arteries

Interventions

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

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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 = 180 / 95 mmHg)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)