Diabetes Mellitus, Type 2SitWiseNCT04262128
Sedentary Behavior in Older Women With and Without Type 2 Diabetes
An observational study of Diabetes Mellitus, Type 2 and Healthy, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Sedentary behavior has been linked to cardiovascular morbidity and mortality, and is particularly common in older adults with type 2 diabetes. The purpose of this observational, mixed-methods study is to better understand the relationship between prolonged sedentary behavior and cardiovascular and metabolic health in… Read more about this study
- Who is it for?
- Ages 60 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Healthy
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2020to 11 Oct 2024
- Phase
- Observational
- 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 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy women and women with T2D age 60-75 years.
Who may be able to join
- Female
- Age 60-75 years
- Postmenopausal (self-reported)
- BMI between 25-40 kg/m2
- Participants with T2D:
- T2D confirmed via chart review
- T2D diet controlled or treated with the following acceptable medication treatments: metformin, sulfonylureas, glinides, or glucose absorption blockers
Who cannot join
- Male
- Age <60 or >75 years
- Type 1 diabetes
- Control participants only - HbA1C ≥ 5.7%
- Use of beta blockers or centrally-acting calcium channel blockers (i.e., diltiazem, verapamil) due to potential blunting of cardiorespiratory fitness assessments
- Use of hormone replacement therapy (e.g., estrogen, progesterone, testosterone) (within the past 5 years)
Show all 21Show fewer
- Taking insulin, thiazolidinediones (e.g., rosiglitazone), glucagon-like peptide-1 (GLP1) agonists (e.g., exenatide), dipeptidyl peptidase-4 (DPP4) inhibitors (e.g., sitagliptin) or any medication for the treatment of T2D other than those listed above in the inclusion criteria
- Uncontrolled hypertension at rest (systolic >160 or diastolic >110 mmHg)
- Obstructive pulmonary disease or asthma with a forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio <70% of predicted
- Any of the following conditions:
- Uncontrolled T2D (HbA1C >9.0%)
- Unstable angina
- Recent myocardial infarction, cardiac surgery, or vascular surgery (<3 months)
- Heart failure
- Peripheral artery disease (based on report of symptomatic claudication or ankle brachial index testing)
- Anemia (tHb <10 mg/dL)
- Hepatic or renal disease
- Severe arthritis or mobility impairment that would interfere with exercise testing
- Current tobacco or marijuana use or nicotine use within the last year
- Dementia or evidence of cognitive impairment (Mini-Cog score < 3)
- Engaging in >150 minutes/week of moderate to vigorous physical activity (assessed via Low-Level Physical Activity Recall questionnaire)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Prolonged Sedentary Behavior in Older Women With and Without Type 2 Diabetes: Knowledge, Engagement, and Relationship to Cardiometabolic Risk
Sedentary behavior has been linked to cardiovascular morbidity and mortality, and is particularly common in older adults with type 2 diabetes. The purpose of this observational, mixed-methods study is to better understand the relationship between prolonged sedentary behavior and cardiovascular and metabolic health in older women.
Read the detailed description
The investigators will recruit 20 women age 60-75 years, n=10 with uncomplicated type 2 diabetes (T2D) and n=10 healthy controls. Participants will wear two accelerometers and a continuous glucose monitor (CGM) for two different periods of 7 days for objective assessment of physical activity, sedentary behavior, and blood glucose, respectively, and complete a graded exercise test (cardiorespiratory fitness), assessment of insulin sensitivity (hyperinsulinemic-euglycemic clamp) and single leg exercise using near-infrared spectroscopy (microvascular function). Participants will also complete a semi-structured qualitative interview to understand knowledge and attitudes toward sedentary behavior and questionnaires to assess the relationship between modifiable psychological and behavioral factors and sedentary behavior.
The aims of the study are to:
- Compare objectively-measured, free-living physical activity and sedentary behavior between older women with and without T2D.
- Evaluate the relationship between prolonged bouts of sedentary behavior, cardiorespiratory fitness, glucose control, insulin sensitivity, and skeletal muscle microvascular function in older women with and without T2D.
- Assess knowledge and attitudes toward sedentary behavior and characterize the relationship between knowledge and attitudes toward sedentary behavior and modifiable psychological and behavioral factors in older women with T2D.
- Evaluate the relationship between sedentary behavior, mood states, and meaning salience during "normal" life and the period of confinement imposed by the COVID-19 epidemic.
- Conditions
- Diabetes Mellitus, Type 2, Healthy
- Keywords
- diabetes, sedentary behavior, cardiovascular disease
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Sedentary Behavior, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes Mellitus | women age 60-75 years with uncomplicated type 2 diabetes mellitus | |
| Healthy Controls | healthy women age 60-75 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
time sedentary measured via triaxial accelerometer
Measured: 7 days
average sedentary bout length measured via triaxial accelerometer
Measured: 7 days
cardiorespiratory fitness
peak volume of oxygen consumption (VO2 peak) in ml/kg/min measured via graded exercise test
Measured: 8-12 minutes
insulin sensitivity
glucose infusion rate in mg/kg/min as measured via hyperinsulinemic-euglycemic clamp
Measured: 3 hours
change in skeletal muscle deoxygenated hemoglobin concentration during single leg calf exercise measured via near-infrared spectroscopy
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start30 Apr 2020
- Primary completion11 Oct 2024
- Study completion11 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary O Whipple, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262128
- Sponsor's protocol ID
- 19-2758
- Acronym
- SitWise
- Status last verified
- May 2025
- First submitted
- 6 Feb 2020
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Whipple MO, Scalzo RL, Bolt M, Pinto AJ, Abushamat LA, Clark EW, Huebschmann AG, Schauer IE, Bergouignan A, Reusch JEB, Regensteiner JG. Prolonged Sedentary Behavior and Cardiometabolic Risk in Older Women With and Without Type 2 Diabetes: The SitWise Study. J Womens Health (Larchmt). 2026 Oct 26:15409996261499484. doi: 10.1177/15409996261499484. Online ahead of print.
PubMed 42934948
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Sedentary Behavior in Older Women With and Without Type 2 Diabetes: Knowledge, Engagement, and Relationship to Cardiometabolic Risk
- ClinicalTrials.gov ID
- NCT04262128
- Acronym / sponsor ID
- SitWise / 19-2758
- Conditions
- Diabetes Mellitus, Type 2, Healthy
- Keywords
- diabetes, sedentary behavior, cardiovascular disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 11 Oct 2024 (actual)
- Study completion
- 11 Oct 2024 (actual)
- First posted
- 10 Feb 2020 (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.
Sedentary behavior has been linked to cardiovascular morbidity and mortality, and is particularly common in older adults with type 2 diabetes. The purpose of this observational, mixed-methods study is to better understand the relationship between prolonged sedentary behavior and cardiovascular and metabolic health in older women.
Detailed description
The investigators will recruit 20 women age 60-75 years, n=10 with uncomplicated type 2 diabetes (T2D) and n=10 healthy controls. Participants will wear two accelerometers and a continuous glucose monitor (CGM) for two different periods of 7 days for objective assessment of physical activity, sedentary behavior, and blood glucose, respectively, and complete a graded exercise test (cardiorespiratory fitness), assessment of insulin sensitivity (hyperinsulinemic-euglycemic clamp) and single leg exercise using near-infrared spectroscopy (microvascular function). Participants will also complete a semi-structured qualitative interview to understand knowledge and attitudes toward sedentary behavior and questionnaires to assess the relationship between modifiable psychological and behavioral factors and sedentary behavior.
The aims of the study are to:
- Compare objectively-measured, free-living physical activity and sedentary behavior between older women with and without T2D.
- Evaluate the relationship between prolonged bouts of sedentary behavior, cardiorespiratory fitness, glucose control, insulin sensitivity, and skeletal muscle microvascular function in older women with and without T2D.
- Assess knowledge and attitudes toward sedentary behavior and characterize the relationship between knowledge and attitudes toward sedentary behavior and modifiable psychological and behavioral factors in older women with T2D.
- Evaluate the relationship between sedentary behavior, mood states, and meaning salience during "normal" life and the period of confinement imposed by the COVID-19 epidemic.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes Mellitus | – | –women age 60-75 years with uncomplicated type 2 diabetes mellitus |
| Healthy Controls | – | –healthy women age 60-75 years |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy women and women with T2D age 60-75 years.
Key inclusion criteria (7 listed)
- Female
- Age 60-75 years
- Postmenopausal (self-reported)
- BMI between 25-40 kg/m2
- Participants with T2D:
Key exclusion criteria (21 listed)
- Male
- Age <60 or >75 years
- Type 1 diabetes
- Control participants only - HbA1C ≥ 5.7%
- Use of beta blockers or centrally-acting calcium channel blockers (i.e., diltiazem, verapamil) due to potential blunting of cardiorespiratory fitness assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
time sedentary measured via triaxial accelerometer
Time frame: 7 days
average sedentary bout length measured via triaxial accelerometer
Time frame: 7 days
cardiorespiratory fitness
Time frame: 8-12 minutes
peak volume of oxygen consumption (VO2 peak) in ml/kg/min measured via graded exercise test
insulin sensitivity
Time frame: 3 hours
glucose infusion rate in mg/kg/min as measured via hyperinsulinemic-euglycemic clamp
change in skeletal muscle deoxygenated hemoglobin concentration during single leg calf exercise measured via near-infrared spectroscopy
Time frame: 30 minutes
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 30 May 2025.
- Derived from this study: PubMed 42934948Whipple MO, Scalzo RL, Bolt M, Pinto AJ, Abushamat LA, Clark EW, Huebschmann AG, Schauer IE, Bergouignan A, Reusch JEB, Regensteiner JG. Prolonged Sedentary Behavior and Cardiometabolic Risk in Older Women With and Without Type 2 Diabetes: The SitWise Study. J Womens Health (Larchmt). 2026 Oct 26:15409996261499484. doi: 10.1177/15409996261499484. Online ahead of print.
- Individual participant dataSharing planned: No
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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 principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Healthy, run by University of Colorado, Denver 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 7 inclusion and 21 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 30 May 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?
time sedentary measured via triaxial accelerometer (time frame: 7 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04262128, which also lists 1 linked publication.
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 30 May 2025.