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

NCT ID: NCT06830486

Last Updated: 2025-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-14

Study Completion Date

2023-10-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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SERM

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

No intervention

Intervention Type 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

These patients are being treated with an aromatase inhibitor for at least one year prior to enrolling in the study.

No intervention

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Colorado State University

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca Scalzo, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University Of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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21-3245.cc

Identifier Type: -

Identifier Source: org_study_id

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