Sedentary Behavior in Older Women With and Without Type 2 Diabetes (SitWise)
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|ClinicalTrials.gov Identifier: NCT04262128|
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : May 5, 2020
|Condition or disease|
|Diabetes Mellitus, Type 2 Healthy|
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 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 Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Prolonged Sedentary Behavior in Older Women With and Without Type 2 Diabetes: Knowledge, Engagement, and Relationship to Cardiometabolic Risk|
|Actual Study Start Date :||April 30, 2020|
|Estimated Primary Completion Date :||August 30, 2021|
|Estimated Study Completion Date :||August 30, 2021|
Type 2 Diabetes Mellitus
women age 60-75 years with uncomplicated type 2 diabetes mellitus
healthy women age 60-75 years
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04262128
|Contact: Mary O Whipple, PhDfirstname.lastname@example.org|
|Contact: Kristina Chapman, BSemail@example.com|
|United States, Colorado|
|University of Colorado Anschutz Medical Campus||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Kristina Chapman, BS 720-848-6690 firstname.lastname@example.org|
|Principal Investigator:||Mary O Whipple, PhD||University of Colorado, Denver|