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Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk

RECRUITINGSponsored by Mayo Clinic
Actively Recruiting
SponsorMayo Clinic
Started2023-11-16
Est. completion2026-12-01
Eligibility
SexFEMALE
Healthy vol.Accepted
Locations1 site

Summary

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

Eligibility

Sex: FEMALEHealthy volunteers accepted
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

Conditions3

Breast CancerDiabetesHER2 Positive Breast Carcinoma

Locations1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office855-776-0015mayocliniccancerstudies@mayo.edu

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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