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Sedentary Behavior in Older Women With and Without Type 2 Diabetes

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Conditions

Diabetes Mellitus, Type 2Healthydiabetessedentary behaviorcardiovascular disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prolonged Sedentary Behavior in Older Women With and Without Type 2 Diabetes: Knowledge, Engagement, and Relationship to Cardiometabolic Risk

Quick Facts

Study Start:2020-04-30
Study Completion:2024-10-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04262128

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years to 75 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female
  2. * Age 60-75 years
  3. * Postmenopausal (self-reported)
  4. * BMI between 25-40 kg/m2
  5. * Participants with T2D:
  6. * T2D confirmed via chart review
  7. * T2D diet controlled or treated with the following acceptable medication treatments: metformin, sulfonylureas, glinides, or glucose absorption blockers
  1. * Male
  2. * Age \<60 or \>75 years
  3. * Type 1 diabetes
  4. * Control participants only - HbA1C ≥ 5.7%
  5. * Use of beta blockers or centrally-acting calcium channel blockers (i.e., diltiazem, verapamil) due to potential blunting of cardiorespiratory fitness assessments
  6. * Use of hormone replacement therapy (e.g., estrogen, progesterone, testosterone) (within the past 5 years)
  7. * 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
  8. * Uncontrolled hypertension at rest (systolic \>160 or diastolic \>110 mmHg)
  9. * Obstructive pulmonary disease or asthma with a forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio \<70% of predicted
  10. * Any of the following conditions:
  11. * Uncontrolled T2D (HbA1C \>9.0%)
  12. * Unstable angina
  13. * Recent myocardial infarction, cardiac surgery, or vascular surgery (\<3 months)
  14. * Heart failure
  15. * Peripheral artery disease (based on report of symptomatic claudication or ankle brachial index testing)
  16. * Anemia (tHb \<10 mg/dL)
  17. * Hepatic or renal disease
  18. * Severe arthritis or mobility impairment that would interfere with exercise testing
  19. * Current tobacco or marijuana use or nicotine use within the last year
  20. * Dementia or evidence of cognitive impairment (Mini-Cog score \< 3)
  21. * Engaging in \>150 minutes/week of moderate to vigorous physical activity (assessed via Low-Level Physical Activity Recall questionnaire)

Contacts and Locations

Principal Investigator

Mary O Whipple, PhD
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver

Study Locations (Sites)

University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Mary O Whipple, PhD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-04-30
Study Completion Date2024-10-11

Study Record Updates

Study Start Date2020-04-30
Study Completion Date2024-10-11

Terms related to this study

Keywords Provided by Researchers

  • diabetes
  • sedentary behavior
  • cardiovascular disease

Additional Relevant MeSH Terms

  • Diabetes Mellitus, Type 2
  • Healthy