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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Type 2 Diabetes
• Intervention / Treatment: Behavioral: prolonged SB; Behavioral: SB broken 1; Behavioral: SB broken 2

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary O Whipple, PhD, RN, PHN; Phone Number: 612-625-4470; Email: whipp042@umn.edu
• Study Contact Backup: Name: study coordinator; Phone Number: 6126265823; Email: sittingresearch@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • Recruiting
      • University of Minnesota
      • Contact: Mary O Whipple, PhD, RN, PHN; Phone Number: 612-625-4470; Email: whipp042@umn.edu
      • Contact: PhD, RN, PHN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CON; Control group	Behavioral: prolonged SB; 4 hours of prolonged SB
Experimental: Break	Behavioral: SB broken 1; 4 hours of SB broken up by 5 minutes of self-paced walking every hour
Experimental: BOUT	Behavioral: SB broken 2; 4 hours of SB with one 20-minute bout of self-paced walking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
iAUC of SBP	Net incremental area under the curve (iAUC) of systolic blood pressure (SBP)	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Net iAUC of DBP	Net iAUC of diastolic blood pressure	90 days
Net iAUC of of MAP	Net iAUC of mean arterial pressure	90 days
Net iAUC of HR	Net iAUC of heart rate	90 days

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Mary O Whipple, PhD, RN, PHN, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: STEP Up T2D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No