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CompletedNCT04262128SitWiseUpdated May 30, 2025

Sedentary Behavior in Older Women With and Without Type 2 Diabetes

An observational study in Diabetes Mellitus, Type 2 and Healthy, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to female participants aged 60 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-30.

Sponsored by University of Colorado, Denver · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
28
Ages
60 Years to 75 Years
Sex
Female
01

Study 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.

Read the 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.
02

Conditions studied

  • Diabetes Mellitus, Type 2
  • Healthy

Keywords

  • diabetes
  • sedentary behavior
  • cardiovascular disease
03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 28 is below the median of 233 across 2,218 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

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)
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
28 participants (actual)
Patient registry
No

Groups and cohorts

  • Type 2 Diabetes Mellitus

    women age 60-75 years with uncomplicated type 2 diabetes mellitus

  • Healthy Controls

    healthy women age 60-75 years

06

What researchers measure

Primary outcomes

  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

    peak volume of oxygen consumption (VO2 peak) in ml/kg/min measured via graded exercise test

    Time frame: 8-12 minutes

  4. insulin sensitivity

    glucose infusion rate in mg/kg/min as measured via hyperinsulinemic-euglycemic clamp

    Time frame: 3 hours

  5. change in skeletal muscle deoxygenated hemoglobin concentration during single leg calf exercise measured via near-infrared spectroscopy

    Time frame: 30 minutes

07

Study locations

1 site
  • University of Colorado Anschutz Medical Campus
    Aurora, Colorado 80045, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04262128
Lead sponsor
University of Colorado, Denver
Responsible party
Sponsor
First posted
Feb 10, 2020
Start date
Apr 30, 2020
Primary completion
Oct 11, 2024
Completion
Oct 11, 2024
Last update
May 30, 2025

Study contacts

Mary O Whipple, PhD
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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