Status:
RECRUITING
Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk
Lead Sponsor:
Mayo Clinic
Conditions:
HER2-Positive Breast Carcinoma
Eligibility:
FEMALE
Brief Summary
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 or ductal carcinoma in situ (DCIS) on various ind...
Eligibility Criteria
Inclusion
- Post-menopausal women with hormone receptor positive breast cancer or ductal carcinoma in situ (DCIS). 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
- 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
Key Trial Info
Start Date :
November 16 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06557057
Start Date
November 16 2023
End Date
December 1 2026
Last Update
September 22 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905