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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05838586
• Other study ID #: STEP Up T2D
• Status: Recruiting
• Phase: N/A
• Start date: July 31, 2023
• Est. completion date: July 31, 2026

Study information

• Verified date: July 2023
• Source: University of Minnesota
• Contact: Mary O Whipple, PhD, RN, PHN
• Phone: 612-625-4470
• Email: whipp042[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• prolonged SB
4 hours of prolonged SB
• SB broken 1
4 hours of SB broken up by 5 minutes of self-paced walking every hour
• SB broken 2
4 hours of SB with one 20-minute bout of self-paced walking

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	iAUC of SBP	Net incremental area under the curve (iAUC) of systolic blood pressure (SBP)	90 days
Secondary	Net iAUC of DBP	Net iAUC of diastolic blood pressure	90 days
Secondary	Net iAUC of of MAP	Net iAUC of mean arterial pressure	90 days
Secondary	Net iAUC of HR	Net iAUC of heart rate	90 days