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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
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief 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 older women.

Condition or disease
Diabetes Mellitus, Type 2 Healthy

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 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:

  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.
Study Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Type 2 Diabetes Mellitus
women age 60-75 years with uncomplicated type 2 diabetes mellitus
Healthy Controls
healthy women age 60-75 years


Outcome Measures
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Primary Outcome Measures :
  1. time sedentary measured via triaxial accelerometer [ Time Frame: 7 days ]
  2. average sedentary bout length measured via triaxial accelerometer [ Time Frame: 7 days ]
  3. cardiorespiratory fitness [ Time Frame: 8-12 minutes ]
    peak volume of oxygen consumption (VO2 peak) in ml/kg/min measured via graded exercise test

  4. insulin sensitivity [ Time Frame: 3 hours ]
    glucose infusion rate in mg/kg/min as measured via hyperinsulinemic-euglycemic clamp

  5. change in skeletal muscle deoxygenated hemoglobin concentration during single leg calf exercise measured via near-infrared spectroscopy [ Time Frame: 30 minutes ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy women and women with T2D age 60-75 years.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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)
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Mary O Whipple, PhD 303-724-2255 mary.whipple@cuanschutz.edu
Contact: Kristina Chapman, BS 720-848-6690 kristina.chapman@cuanschutz.edu

Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Kristina Chapman, BS    720-848-6690    kristina.chapman@cuanschutz.edu   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Mary O Whipple, PhD University of Colorado, Denver
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04262128    
Other Study ID Numbers: 19-2758
First Posted: February 10, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
diabetes
sedentary behavior
cardiovascular disease
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases