COMPLETED

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-07-31

Study Completion:2025-08-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05838586

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Principal Investigator

Mary O Whipple, PhD, RN, PHN

PRINCIPAL_INVESTIGATOR

University of Minnesota

Study Locations (Sites)

University of Minnesota

Minneapolis, Minnesota, 55414

United States

Collaborators and Investigators

Sponsor: University of Minnesota

Mary O Whipple, PhD, RN, PHN, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-31

Study Completion Date2025-08-18

Study Record Updates

Study Start Date2023-07-31

Study Completion Date2025-08-18

Terms related to this study

Additional Relevant MeSH Terms

Type 2 Diabetes
Cardiovascular Diseases