Sedentary Behavior in Older Women With and Without Type 2 Diabetes
NCT ID: NCT04262128
Last Updated: 2025-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
28 participants
OBSERVATIONAL
2020-04-30
2024-10-11
Brief Summary
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Detailed Description
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The aims of the study are to:
1. Compare objectively-measured, free-living physical activity and sedentary behavior between older women with and without T2D.
2. 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.
3. 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.
4. 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
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Type 2 Diabetes Mellitus
women age 60-75 years with uncomplicated type 2 diabetes mellitus
No interventions assigned to this group
Healthy Controls
healthy women age 60-75 years
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
Exclusion Criteria
* 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)
60 Years
75 Years
FEMALE
Yes
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Mary O Whipple, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Countries
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Other Identifiers
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19-2758
Identifier Type: -
Identifier Source: org_study_id
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