Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk
Purpose
This study assesses the effect of hormone directed treatment for breast cancer on glucose metabolism.
Condition
- HER2-Positive Breast Carcinoma
Eligibility
- Eligible Ages
- All ages
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Observational | Patients undergo blood sample collection, glucose testing, DEXA scan to measure body composition, complete a questionnaire and have their medical records reviewed on study. |
|
Recruiting Locations
Rochester, Minnesota 55905
More Details
- Status
- Recruiting
- Sponsor
- Mayo Clinic
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.