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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Breast cancer survivors prescribed endocrine therapy for at least one year

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SERM; These patients are being treated with a SERM for at least one year prior to enrolling in the study.	Other: No intervention; 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.
Aromatase Inhibitor; These patients are being treated with an aromatase inhibitor for at least one year prior to enrolling in the study.	Other: No intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin Resistance	Insulin resistance will be measured through oral glucose tolerance testing	Immediately after the consent form is signed
Body Composition	Body composition will be measured through DEXA scan	Immediately after the insulin resistance measurement
Maximal Exercise Capacity	Maximal exercise capacity measured through graded exercise test on stationary bicycle	Within 2-60 days of insulin resistance measurement
Daily Activity	Daily activity measured using activity monitor	2-60 days following insulin resistance measurement

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Colorado State University
• Investigators: Principal Investigator: Rebecca Scalzo, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): February 17, 2025

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Exercise; Breast Cancer; Insulin Resistance; Body Composition; Endocrine Therapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Metabolic Diseases; Glucose Metabolism Disorders; Skin Diseases; Breast Diseases; Hyperinsulinism; Behavior; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Insulin Resistance; Motor Activity
• Other Study ID Numbers: 21-3245.cc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No