Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-Interventional Study.
- Who it may be relevant to
- Registry conditions: HER2-Positive Breast Carcinoma. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study assesses the effect of hormone directed treatment for breast cancer on glucose metabolism.
Detailed description
PRIMARY OBJECTIVE:
I. Assess the impact of endocrine adjuvant therapy with aromatase inhibitors in women with hormone receptor positive breast cancer, ductal carcinoma in situ (cancer, DCIS ), or women with other high risk breast conditions, on various indices of glucose homeostasis, utilizing oral minimal model assessment, in comparison to healthy post menopausal women and another cohort of women on tamoxifen.
OUTLINE: This is an observational study.
Patients undergo blood sample collection, glucose testing, dual-energy x-ray absorptiometry (DEXA) scan to measure body composition, complete a questionnaire and have their medical records reviewed on study.
Interventions
- Other Non-Interventional Study
Non-Interventional Study
Primary outcome measures
- Disposition Index (DI) [Time frame: Baseline; up to 1 year]
- Glucose homeostasis - tamoxifen compared to no treatment [Time frame: Baseline; up to 1 year]
- Glucose homeostasis - aromatase inhibitor compared to tamoxifen [Time frame: Baseline; up to 1 year]
Eligibility criteria
Inclusion criteria
- Post-menopausal women with hormone receptor positive breast cancer, ductal carcinoma in situ (DCIS), or with other high risk breast conditions. Post-menopause will be defined as women who experience 12 months of amenorrhea or have undergone bilateral salpingo-oophorectomy.
- 25 women who are planning to start or are within 6 months of starting treatment with aromatase inhibitors, after consultation in breast clinic and cancer center.
- 25 women who will be starting Tamoxifen (comparative group)
- 25 healthy post menopausal women will also be recruited.
Exclusion criteria
- Established diagnosis of diabetes
- Therapy with medications that could affect glucose metabolism
- Screening fasting glucose ≥ 126 mg/dl, and/or HbA1c ≥ 6.5%
- History of upper GI surgery that alters gastric emptying or causing malabsorption e.g., bariatric surgery, fundoplication
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT06557057 · 23-005595