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

NCT05838586 | Completed

• 1 other identifier: STEP Up T2D
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• iAUC of SBP

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

  90 days

Secondary Outcomes (3)

• Net iAUC of DBP

  90 days

• Net iAUC of of MAP

  90 days

• Net iAUC of HR

  90 days

Study Arms (3)

CON

EXPERIMENTAL

Control group

Behavioral: prolonged SB

Break

EXPERIMENTAL

Behavioral: SB broken 1

BOUT

EXPERIMENTAL

Behavioral: SB broken 2

Interventions

prolonged SB BEHAVIORAL

4 hours of prolonged SB

CON

SB broken 1 BEHAVIORAL

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

Break

SB broken 2 BEHAVIORAL

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

BOUT

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mary O Whipple, PhD, RN, PHN

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will complete three interventions in a randomized order, separated by \>=6 and \<90 days. The interventions are: 1. 4 hours of prolonged SB (control, CON) 2. 4 hours of SB broken up by 5 minutes of self-paced walking every hour (BREAK) 3. 4 hours of SB with one 20-minute bout of self-paced walking (BOUT)

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 1, 2023
• Study Start: July 31, 2023
• Primary Completion: August 18, 2025
• Study Completion: August 18, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

US (1)