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Completed

NCT Number: NCT05838586

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

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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Key information

Conditions

Type 2 Diabetes Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prolonged SB

Behavioral

4 hours of prolonged SB

SB broken 1

Behavioral

4 hours of SB broken up by 5 minutes of self-paced walking every hour

SB broken 2

Behavioral

4 hours of SB with one 20-minute bout of self-paced walking

Primary outcomes

  1. iAUC of SBP

    Time frame: 90 days

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

Secondary outcomes

  1. Net iAUC of DBP

    Time frame: 90 days

    Net iAUC of diastolic blood pressure

  2. Net iAUC of of MAP

    Time frame: 90 days

    Net iAUC of mean arterial pressure

  3. Net iAUC of HR

    Time frame: 90 days

    Net iAUC of heart rate

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 1, 2023
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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