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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT06830486
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study Start: 2022-02-14
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Study First Submitted: 2023-12-01
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Study First Posted: 2025-02-17
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States