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OpenTrials
Completed

NCT Number: NCT06830486

Effects of Activity on Diabetes Risk Among Breast Cancer Survivors on Endocrine Therapy (ABIDE)

The aim of this study is to learn more about how physical activity and cardiorespiratory fitness are related to diabetes risk among breast cancer patients prescribed an endocrine therapy.

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

University Of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

About this study

80 women between the ages of 18-80 years will be recruited for this study. The study design consists of two separate in-person visits to University of Colorado Anschutz Medical Campus or Colorado State University. The study consists of glucose testing, a body composition scan, exercise testing, and a two-week period of free living activity monitoring.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female
  • diagnosed with breast cancer
  • age 18-80 years
  • Completed surgery, chemo- and/or radiation therapy
  • Prescribed aromatase inhibitor or SERM for at least one year from the time of screening

Exclusion criteria

  • Age < 18 or > 80
  • Type 1 diabetes
  • Type 2 diabetes
  • Prescribed anti-hyperglycemic medication, insulin, or sulfonylurea.
  • Pregnant, breastfeeding or planning to become pregnant in next 2 months
  • Have absolute contraindications to exercise testing which are:
  • Unstable angina
  • Recent myocardial infarction, cardiac surgery, or vascular surgery (<3 months)
  • Uncontrolled high blood pressure
  • Heart failure
  • Peripheral artery disease (based on report of symptomatic claudication)
  • Hepatic or renal disease
  • Severe arthritis or mobility impairment that would interfere with exercise testing
  • Suspected cognitive impairment that would prevent understanding or comprehension of study procedures.

Treatment and study plan

No intervention

Other

No intervention is performed. Participants who have been treated with either a SERM or aromatase inhibitor are recruited and analyzed in separate groups, but the study design for all participants is identical.

Primary outcomes

  1. Insulin Resistance

    Time frame: Immediately after the consent form is signed

    Insulin resistance will be measured through oral glucose tolerance testing

  2. Body Composition

    Time frame: Immediately after the insulin resistance measurement

    Body composition will be measured through DEXA scan

  3. Maximal Exercise Capacity

    Time frame: Within 2-60 days of insulin resistance measurement

    Maximal exercise capacity measured through graded exercise test on stationary bicycle

  4. Daily Activity

    Time frame: 2-60 days following insulin resistance measurement

    Daily activity measured using activity monitor

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Colorado State University

Registry information

Official study title

The Effects of Cardiorespiratory Fitness, Physical Activity and Sedentary Behavior on Insulin Resistance Among Breast Cancer Survivors Being Treated With Anti-estrogen Endocrine Therapies

Acronym: ABIDE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 17, 2025
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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