Type 2 DiabetesNCT05838586
Sex Differences in the effecTs of brEaking uP Sedentary Behavior on vascUlar Function in Type 2 Diabetes
A study testing prolonged SB, SB broken 1 and SB broken 2 in people with Type 2 Diabetes and Cardiovascular Diseases, run by University of Minnesota at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Type 2 Diabetes, Cardiovascular Diseases
- What is being tested?
- prolonged SB, SB broken 1 and SB broken 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2023to 18 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
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.
- Conditions
- Type 2 Diabetes, Cardiovascular Diseases
- Being tested
- prolonged SB, SB broken 1, SB broken 2
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prolonged SBBehavioural
4 hours of prolonged SB
SB broken 1Behavioural
4 hours of SB broken up by 5 minutes of self-paced walking every hour
SB broken 2Behavioural
4 hours of SB with one 20-minute bout of self-paced walking
| Study group | Role | What they receive |
|---|---|---|
| CON | Experimental | Control group Receives: Behavioral: prolonged SB |
| Break | Experimental | Not described Receives: Behavioral: SB broken 1 |
| BOUT | Experimental | Not described Receives: Behavioral: SB broken 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
iAUC of SBP
Net incremental area under the curve (iAUC) of systolic blood pressure (SBP)
Measured: 90 days
Secondary outcomes (3)
Net iAUC of DBP
Net iAUC of diastolic blood pressure
Measured: 90 days
Net iAUC of of MAP
Net iAUC of mean arterial pressure
Measured: 90 days
Net iAUC of HR
Net iAUC of heart rate
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start31 Jul 2023
- Primary completion18 Aug 2025
- Study completion18 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will complete three interventions in a randomized order, separated by \>=6 and \<90 days. The interventions are: 1. 4 hours of prolonged SB (control, CON) 2. 4 hours of SB broken up by 5 minutes of self-paced walking every hour (BREAK) 3. 4 hours of SB with one 20-minute bout of self-paced walking (BOUT)
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary O Whipple, PhD, RN, PHN, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838586
- Sponsor's protocol ID
- STEP Up T2D
- Status last verified
- Aug 2025
- First submitted
- 13 Apr 2023
- Last updated
- 19 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Differences in the effecTs of brEaking uP Sedentary Behavior on vascUlar Function in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05838586
- Acronym / sponsor ID
- STEP Up T2D
- Conditions
- Type 2 Diabetes, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- 18 Aug 2025 (actual)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will complete three interventions in a randomized order, separated by >=6 and <90 days. The interventions are: 1. 4 hours of prolonged SB (control, CON) 2. 4 hours of SB broken up by 5 minutes of self-paced walking every hour (BREAK) 3. 4 hours of SB with one 20-minute bout of self-paced walking (BOUT)
| Arm | Type | Receives |
|---|---|---|
| CON | Experimental | Behavioral: prolonged SBControl group |
| Break | Experimental | Behavioral: SB broken 1 |
| BOUT | Experimental | Behavioral: SB broken 2 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prolonged SB4 hours of prolonged SB | Behavioural | CON |
| SB broken 14 hours of SB broken up by 5 minutes of self-paced walking every hour | Behavioural | Break |
| SB broken 24 hours of SB with one 20-minute bout of self-paced walking | Behavioural | BOUT |
Primary outcome
iAUC of SBP
Time frame: 90 days
Net incremental area under the curve (iAUC) of systolic blood pressure (SBP)
3 secondary outcomes
Net iAUC of DBP
Time frame: 90 days
Net iAUC of of MAP
Time frame: 90 days
Net iAUC of HR
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary O Whipple, PhD, RN, PHN principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prolonged SB, SB broken 1 and SB broken 2 in people with Type 2 Diabetes and Cardiovascular Diseases, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
iAUC of SBP (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.