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

Sponsor
University of Minnesota (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05838586
Collaborator
(none)
80
1
3
38
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: prolonged SB
  • Behavioral: SB broken 1
  • Behavioral: SB broken 2
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Participants will complete three interventions in a randomized order, separated by >=6 and <90 days. The interventions are: 4 hours of prolonged SB (control, CON) 4 hours of SB broken up by 5 minutes of self-paced walking every hour (BREAK) 4 hours of SB with one 20-minute bout of self-paced walking (BOUT)Participants will complete three interventions in a randomized order, separated by >=6 and <90 days. The interventions are:4 hours of prolonged SB (control, CON) 4 hours of SB broken up by 5 minutes of self-paced walking every hour (BREAK) 4 hours of SB with one 20-minute bout of self-paced walking (BOUT)
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Sex Differences in the effecTs of brEaking uP Sedentary Behavior on vascUlar Function in Type 2 Diabetes
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2026
Anticipated Study Completion Date :
Jul 1, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. iAUC of SBP [90 days]

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

Secondary Outcome Measures

  1. Net iAUC of DBP [90 days]

    Net iAUC of diastolic blood pressure

  2. Net iAUC of of MAP [90 days]

    Net iAUC of mean arterial pressure

  3. Net iAUC of HR [90 days]

    Net iAUC of heart rate

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Minnesota Minneapolis Minnesota United States 55414

Sponsors and Collaborators

  • University of Minnesota

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT05838586
Other Study ID Numbers:
  • STEP Up T2D
First Posted:
May 1, 2023
Last Update Posted:
May 1, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 1, 2023