Breast CancerABIDENCT06830486
Effects of Activity on Diabetes Risk Among Breast Cancer Survivors on Endocrine Therapy (ABIDE)
An observational study of Breast Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2022to 31 Oct 2023
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer survivors prescribed endocrine therapy for at least one year
Who may be able to join
- 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
Who cannot join
- 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:
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- No intervention
- Keywords
- Exercise, Breast Cancer, Endocrine Therapy, Insulin Resistance, Body Composition
- Medical subject headings
- Breast Neoplasms, Motor Activity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SERM | These patients are being treated with a SERM for at least one year prior to enrolling in the study. Receives: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Resistance
Insulin resistance will be measured through oral glucose tolerance testing
Measured: Immediately after the consent form is signed
Body Composition
Body composition will be measured through DEXA scan
Measured: Immediately after the insulin resistance measurement
Maximal Exercise Capacity
Maximal exercise capacity measured through graded exercise test on stationary bicycle
Measured: Within 2-60 days of insulin resistance measurement
Daily Activity
Daily activity measured using activity monitor
Measured: 2-60 days following insulin resistance measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start14 Feb 2022
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado State University
- Responsible party
- Sponsor
- Investigators
- Rebecca Scalzo, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830486
- Sponsor's protocol ID
- 21-3245.cc
- Acronym
- ABIDE
- Status last verified
- Feb 2026
- First submitted
- 1 Dec 2023
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06830486
- Acronym / sponsor ID
- ABIDE / 21-3245.cc
- Conditions
- Breast Cancer
- Keywords
- Exercise, Breast Cancer, Endocrine Therapy, Insulin Resistance, Body Composition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Colorado State University
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SERM | – | Other: No interventionThese patients are being treated with a SERM for at least one year prior to enrolling in the study. |
| Aromatase Inhibitor | – | Other: No interventionThese patients are being treated with an aromatase inhibitor for at least one year prior to enrolling in the study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer survivors prescribed endocrine therapy for at least one year
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo 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. | Other | Aromatase Inhibitor, SERM |
Primary outcome
Insulin Resistance
Time frame: Immediately after the consent form is signed
Insulin resistance will be measured through oral glucose tolerance testing
Body Composition
Time frame: Immediately after the insulin resistance measurement
Body composition will be measured through DEXA scan
Maximal Exercise Capacity
Time frame: Within 2-60 days of insulin resistance measurement
Maximal exercise capacity measured through graded exercise test on stationary bicycle
Daily Activity
Time frame: 2-60 days following insulin resistance measurement
Daily activity measured using activity monitor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Scalzo, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Resistance (time frame: Immediately after the consent form is signed). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.