Examining how breaking up sitting time affects blood vessel health in older women with type 2 diabetes
Sex Differences in the effecTs of brEaking uP Sedentary Behavior on vascUlar Function in Type 2 Diabetes
NA · University of Minnesota · NCT05838586
This study is testing if taking short or longer walking breaks during sitting can improve blood vessel health in older women with type 2 diabetes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University of Minnesota (other) |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05838586 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of breaking up sedentary behavior on vascular function in older women with type 2 diabetes. It employs a 3-arm crossover randomized controlled design, comparing three different conditions: prolonged sedentary behavior, sedentary behavior interrupted by short walking breaks, and sedentary behavior with a longer walking bout. The study aims to explore not only the overall effects of these conditions but also to identify any sex differences in the outcomes related to cardiovascular risk markers. By focusing on an often-overlooked demographic, this research seeks to fill gaps in existing literature regarding sedentary behavior and its health implications.
Who should consider this trial
Good fit: Ideal candidates for this study are postmenopausal women aged 60 and older who have type 2 diabetes and engage in at least 6 hours of sedentary behavior daily.
Not a fit: Patients with type 1 diabetes, uncontrolled hypertension, or significant physical impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for reducing cardiovascular risk in older women with type 2 diabetes.
How similar studies have performed: While there is limited research specifically targeting older women with type 2 diabetes, studies on breaking up sedentary behavior have shown promising results in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Mary O Whipple, PhD, RN, PHN — University of Minnesota
- Study coordinator: Mary O Whipple, PhD, RN, PHN
- Email: whipp042@umn.edu
- Phone: 612-625-4470
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 2 Diabetes, Cardiovascular Diseases