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

NCT ID: NCT05838586

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2025-08-18

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.

Conditions

Type 2 Diabetes; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

CON

Control group

Group Type: EXPERIMENTAL

prolonged SB

Intervention Type: BEHAVIORAL

4 hours of prolonged SB

Break

Group Type: EXPERIMENTAL

SB broken 1

Intervention Type: BEHAVIORAL

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

BOUT

Group Type: EXPERIMENTAL

SB broken 2

Intervention Type: BEHAVIORAL

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

Interventions

prolonged SB

4 hours of prolonged SB

Intervention Type: BEHAVIORAL

SB broken 1

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

Intervention Type: BEHAVIORAL

SB broken 2

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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary O Whipple, PhD, RN, PHN

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

STEP Up T2D

Identifier Type: -

Identifier Source: org_study_id