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Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk

NCT06557057

RecruitingN/A

Sponsor: Mayo Clinic

Conditions: HER2-Positive Breast Carcinoma

Interventions: Non-Interventional Study

Countries: United States

This study assesses the effect of hormone directed treatment for breast cancer on glucose metabolism.

Eligibility overview

Sex: FEMALE

Healthy volunteers: Yes

Study type: OBSERVATIONAL

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

Locations (1)

Rochester, Minnesota, United States