Clinical trial NCT06830486: Effects of Activity on Diabetes Risk Among Breast Cancer Survivors on Endocrine Therapy (ABIDE)
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Exercise
Breast Cancer
Endocrine Therapy
Insulin Resistance
Body Composition
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Colorado State University
First posted: 2025-02-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer survivors prescribed endocrine therapy for at least one year

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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:

  1. Unstable angina
  2. Recent myocardial infarction, cardiac surgery, or vascular surgery (\<3 months)
  3. Uncontrolled high blood pressure
  4. Heart failure
  5. Peripheral artery disease (based on report of symptomatic claudication)
  6. Hepatic or renal disease
  7. Severe arthritis or mobility impairment that would interfere with exercise testing
* Suspected cognitive impairment that would prevent understanding or comprehension of study procedures.

Primary outcomes:
measure: Insulin Resistance
timeFrame: Immediately after the consent form is signed
measure: Body Composition
timeFrame: Immediately after the insulin resistance measurement
measure: Maximal Exercise Capacity
timeFrame: Within 2-60 days of insulin resistance measurement
measure: Daily Activity
timeFrame: 2-60 days following insulin resistance measurement
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University Of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Rebecca Scalzo, PhD
role: PRINCIPAL_INVESTIGATOR
References: