Cardiovascular Diseases, Type 2 Diabetes
Conditions
Brief summary
Type 2 diabetes (T2D) confers a high risk of cardiovascular disease (CVD), particularly among older adults who tend to be physically inactive. Prolonged sedentary behavior (SB) has been shown to negatively influence markers of cardiovascular risk (e.g., blood glucose, blood pressure), even among individuals who are physically active. Most studies that have examined the effects of breaking up SB have focused on young healthy males and prioritized glycemic outcomes. Additionally, sex differences in these outcomes have not been adequately examined. The present study will address these gaps. This 3-arm crossover randomized controlled trial will compare the effects of 3 SB conditions on markers of vascular function. The 3 conditions are: 1) 4 hours of prolonged SB, 2) 4 hours of SB broken up by 5 minutes of self-paced walking every hour, and 3) 4 hours of SB with one 20-minute bout of self-paced walking. In addition to examining the overall effects of each condition, sex differences in physiological responses will be evaluated.
Interventions
BEHAVIORALprolonged SB
4 hours of prolonged SB
BEHAVIORALSB broken 1
4 hours of SB broken up by 5 minutes of self-paced walking every hour
BEHAVIORALSB broken 2
4 hours of SB with one 20-minute bout of self-paced walking
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants will complete three interventions in a randomized order, separated by \>=6 and \<90 days. The interventions are: 1. 4 hours of prolonged SB (control, CON) 2. 4 hours of SB broken up by 5 minutes of self-paced walking every hour (BREAK) 3. 4 hours of SB with one 20-minute bout of self-paced walking (BOUT)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥60 years * Postmenopausal (females only, ≥12 months without a menstrual period) * Type 2 diabetes (hemoglobin A1c ≥6.5% and/or previous diagnosis of type 2 diabetes) * ≥6 hours/day sedentary (assessed via IPAQ) * Willingness to abstain from food, caffeine, alcohol and exercise for \>= 24 hours, and tobacco/smoking for ≥12 hours prior to each intervention visit * Ability to speak and read English
Exclusion criteria
* Type 1 diabetes * Uncontrolled hypertension (resting systolic ≥160 or diastolic ≥110 mmHg) * Initiation of hormone therapy or change in hormone therapy dose/frequency/route of administration in the previous 3 months * Renal dialysis * History of deep vein thrombosis (DVT) * Evidence of cognitive impairment that could impact ability to consent and/or participation (Mini-Cog score \<3) * Achieving physical activity guidelines (≥150 minutes of MVPA/week, assessed via IPAQ)) * Physical impairment or disability that interferes with ability to engage in PA (e.g., severe osteoarthritis, lower extremity amputation \[other than toe(s)/partial foot\], use of a walker or wheelchair, etc.), * Unstable medical/psychiatric condition that could impact study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| iAUC of SBP | 90 days | Net incremental area under the curve (iAUC) of systolic blood pressure (SBP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Net iAUC of DBP | 90 days | Net iAUC of diastolic blood pressure |
| Net iAUC of of MAP | 90 days | Net iAUC of mean arterial pressure |
| Net iAUC of HR | 90 days | Net iAUC of heart rate |
Countries
United States
Outcome results
None listed