Sedentary Behavior in Older Women With and Without Type 2 Diabetes

  • STATUS
    Recruiting
  • days left to enroll
    29
  • participants needed
    20
  • sponsor
    University of Colorado, Denver
Updated on 30 September 2021
metformin
sulfonylurea

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.

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:

  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.

Details
Condition NIDDM, Diabetes Mellitus, Type 2, healthy, Diabetes Mellitus Type 2, type 2 diabetes mellitus, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Clinical Study IdentifierNCT04262128
SponsorUniversity of Colorado, Denver
Last Modified on30 September 2021

Eligibility

Yes No Not Sure

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)

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)
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