Sedentary Behavior in Older Women With and Without Type 2 Diabetes

NCT04262128 | Completed

• 1 other identifier: 19-2758
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Healthy

Keywords

diabetes; sedentary behavior; cardiovascular disease

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Type 2 Diabetes Mellitus

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

Healthy Controls

healthy women age 60-75 years

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Sedentary Behavior; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Mary O Whipple, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 10, 2020
• Study Start: April 30, 2020
• Primary Completion: October 11, 2024
• Study Completion: October 11, 2024
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)