Back to resultsSex Differences in the effecTs of brEaking uP Sedentary Behavior on vascUlar Function in Type 2 Diabetes
Primary Purpose
Type 2 Diabetes, Cardiovascular Diseases
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
prolonged SB
SB broken 1
SB broken 2
Sponsored by
About this trial
This is an interventional supportive care trial for Type 2 Diabetes
Eligibility Criteria
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
Sites / Locations
- University of MinnesotaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
CON
Break
BOUT
Arm Description
Control group
Outcomes
Primary Outcome Measures
iAUC of SBP
Net incremental area under the curve (iAUC) of systolic blood pressure (SBP)
Secondary Outcome Measures
Net iAUC of DBP
Net iAUC of diastolic blood pressure
Net iAUC of of MAP
Net iAUC of mean arterial pressure
Net iAUC of HR
Net iAUC of heart rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05838586
Brief Title
Sex Differences in the effecTs of brEaking uP Sedentary Behavior on vascUlar Function in Type 2 Diabetes
Official Title
Sex Differences in the effecTs of brEaking uP Sedentary Behavior on vascUlar Function in Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2023 (Actual)
Primary Completion Date
July 31, 2026 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Cardiovascular Diseases
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CON
Arm Type
Experimental
Arm Description
Control group
Arm Title
Break
Arm Type
Experimental
Arm Title
BOUT
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
prolonged SB
Intervention Description
4 hours of prolonged SB
Intervention Type
Behavioral
Intervention Name(s)
SB broken 1
Intervention Description
4 hours of SB broken up by 5 minutes of self-paced walking every hour
Intervention Type
Behavioral
Intervention Name(s)
SB broken 2
Intervention Description
4 hours of SB with one 20-minute bout of self-paced walking
Primary Outcome Measure Information:
Title
iAUC of SBP
Description
Net incremental area under the curve (iAUC) of systolic blood pressure (SBP)
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Net iAUC of DBP
Description
Net iAUC of diastolic blood pressure
Time Frame
90 days
Title
Net iAUC of of MAP
Description
Net iAUC of mean arterial pressure
Time Frame
90 days
Title
Net iAUC of HR
Description
Net iAUC of heart rate
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary O Whipple, PhD, RN, PHN
Phone
612-625-4470
Email
whipp042@umn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
study coordinator
Phone
6126265823
Email
sittingresearch@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary O Whipple, PhD, RN, PHN
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary O Whipple, PhD, RN, PHN
Phone
612-625-4470
Email
whipp042@umn.edu
First Name & Middle Initial & Last Name & Degree
PhD, RN, PHN
12. IPD Sharing Statement
Learn more about this trial
Sex Differences in the effecTs of brEaking uP Sedentary Behavior on vascUlar Function in Type 2 Diabetes
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