NCT06557057 Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk
| NCT ID | NCT06557057 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | HER2-Positive Breast Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 66 participants |
| Start Date | 2023-11-16 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 66 participants in total. It began in 2023-11-16 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study assesses the effect of hormone directed treatment for breast cancer on glucose metabolism.
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
Contact & Investigator
Kalpana Muthusamy, MBBS, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic in Rochester
Frequently Asked Questions
Who can join the NCT06557057 clinical trial?
This trial is open to female participants only, studying HER2-Positive Breast Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06557057 currently recruiting?
Yes, NCT06557057 is actively recruiting participants. Contact the research team at mayocliniccancerstudies@mayo.edu for enrollment information.
Where is the NCT06557057 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT06557057 clinical trial?
NCT06557057 is sponsored by Mayo Clinic. The principal investigator is Kalpana Muthusamy, MBBS, MD at Mayo Clinic in Rochester. The trial plans to enroll 66 participants.