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CompletedNCT05838586Updated Aug 19, 2025

Sex Differences in the effecTs of brEaking uP Sedentary Behavior on vascUlar Function in Type 2 Diabetes

An interventional study of prolonged SB and SB broken 1 in Type 2 Diabetes and Cardiovascular Diseases, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-08-19.

Sponsored by University of Minnesota · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
60 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Type 2 Diabetes
  • Cardiovascular Diseases
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In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 34 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    CON

    Control group

    Behavioral: prolonged SB

  • Experimental
    Break

    Behavioral: SB broken 1

  • Experimental
    BOUT

    Behavioral: SB broken 2

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

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What researchers measure

Primary outcomes

  1. iAUC of SBP

    Net incremental area under the curve (iAUC) of systolic blood pressure (SBP)

    Time frame: 90 days

Secondary outcomes

  1. Net iAUC of DBP

    Net iAUC of diastolic blood pressure

    Time frame: 90 days

  2. Net iAUC of of MAP

    Net iAUC of mean arterial pressure

    Time frame: 90 days

  3. Net iAUC of HR

    Net iAUC of heart rate

    Time frame: 90 days

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Study locations

1 site
  • University of Minnesota
    Minneapolis, Minnesota 55414, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05838586
Lead sponsor
University of Minnesota
Responsible party
Sponsor
First posted
May 1, 2023
Start date
Jul 31, 2023
Primary completion
Aug 18, 2025
Completion
Aug 18, 2025
Last update
Aug 19, 2025

Study contacts

Mary O Whipple, PhD, RN, PHN
principal investigator · University of Minnesota

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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