Recruiting
Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk
This study assesses the effect of hormone directed treatment for breast cancer on glucose metabolism.
ClinicalTrials.gov IDNCT06557057
PhaseNot Applicable
Enrollment81
SponsorMayo Clinic
AgeNo minimum reported
SexFEMALE
Conditions studied
HER2-Positive Breast Carcinoma
About this study
This study assesses the effect of hormone directed treatment for breast cancer on glucose metabolism.
Interventions
- Other: Non-Interventional Study — Non-Interventional Study
Primary outcomes
- Disposition Index (DI) (Baseline; up to 1 year)
- Glucose homeostasis - tamoxifen compared to no treatment (Baseline; up to 1 year)
- Glucose homeostasis - aromatase inhibitor compared to tamoxifen (Baseline; up to 1 year)
Eligibility information
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 locations
- Mayo Clinic in Rochester, Rochester, Minnesota 55905 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.