NCT06557057 · Mayo Clinic
Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk
What this study is about
This study assesses the effect of hormone directed treatment for breast cancer on glucose metabolism.
View original scientific description
This study assesses the effect of hormone directed treatment for breast cancer on glucose metabolism.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Rochester, Minnesota
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 31, 2026 · Source of record for eligibility and locations