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

NCT06830486 | Completed

• 1 other identifier: 21-3245.cc
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Exercise; Breast Cancer; Endocrine Therapy; Insulin Resistance; Body Composition

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

SERM

These patients are being treated with a SERM for at least one year prior to enrolling in the study.

Other: No intervention

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

Interventions

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.

Aromatase Inhibitor; SERM

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Biologically female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer survivors prescribed endocrine therapy for at least one year

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Colorado State University: collaborator

Study Sites (1)

University Of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood Samples

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity; Insulin Resistance

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Rebecca Scalzo, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: February 17, 2025
• Study Start: February 14, 2022
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (1)