Sedentary Behavior in Older Women With and Without Type 2 Diabetes (SitWise)

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Diabetes Mellitus, Type 2

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:

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Mary O Whipple, PhD; Phone Number: 303-724-2255; Email: mary.whipple@cuanschutz.edu
• Study Contact Backup: Name: Deirdre Rafferty, MS; Phone Number: 3037241331; Email: deirdre.rafferty@gmail.com

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Anschutz Medical Campus
      • Contact: Ethan Clark, MS; Phone Number: 303-724-1354; Email: ethan.w.clark@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy women and women with T2D age 60-75 years.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time sedentary measured via triaxial accelerometer		7 days
average sedentary bout length measured via triaxial accelerometer		7 days
cardiorespiratory fitness	peak volume of oxygen consumption (VO2 peak) in ml/kg/min measured via graded exercise test	8-12 minutes
insulin sensitivity	glucose infusion rate in mg/kg/min as measured via hyperinsulinemic-euglycemic clamp	3 hours
change in skeletal muscle deoxygenated hemoglobin concentration during single leg calf exercise measured via near-infrared spectroscopy		30 minutes

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Mary O Whipple, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2020
• Primary Completion (Estimated): July 30, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): December 4, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: diabetes; cardiovascular disease; sedentary behavior
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 19-2758

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No