NCT05838586Completed
Sex Differences in the effecTs of brEaking uP Sedentary Behavior on vascUlar Function in Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 19 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 34 (actual)
- First submitted
- 13 Apr 2023
- Start date
- 31 Jul 2023
- Primary completion date
- 18 Aug 2025
- Lead sponsor
- University of Minnesota
- Diseases
- Type 2 diabetes
- NCT number
- NCT05838586
What you commit to
- Study type: Interventional
- Participants enrolled: 34
- From 31 Jul 2023 to the primary completion date, 18 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Initiation of hormone therapy or change in hormone therapy dose/frequency/route of administration in the previous 3 months
Other illness
- Type 1 diabetes
- Uncontrolled hypertension (resting systolic ≥160 or diastolic ≥110 mmHg)
- History of deep vein thrombosis (DVT)
- Evidence of cognitive impairment that could impact ability to consent and/or participation (Mini-Cog score \<3)
- 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
Other
- Renal dialysis
- Achieving physical activity guidelines (≥150 minutes of MVPA/week, assessed via IPAQ))
Who the study is looking for
- 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
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.