Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk

Mayo Clinic

Status: Enrolling

Conditions: HER2-Positive Breast Carcinoma

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other

Identifiers

NCT06557057

NCI-2024-01190 (Registry Identifier)

23-005595 (Other Identifier)

Details and patient eligibility

About

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

Full description

PRIMARY OBJECTIVE:

I. Assess the impact of endocrine adjuvant therapy with aromatase inhibitors in women with hormone receptor positive breast cancer, on various indices of glucose homeostasis, utilizing oral minimal model assessment, in comparison to healthy post menopausal women and another cohort of women on tamoxifen.

OUTLINE: This is an observational study.

Patients undergo blood sample collection, glucose testing, DEXA scan to measure body composition, complete a questionnaire and have their medical records reviewed on study.

Enrollment: 75 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Post-menopausal women with hormone receptor positive breast cancer. 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

Trial design

75 participants in 1 patient group

Observational

Description:

Patients undergo blood sample collection, glucose testing, DEXA scan to measure body composition, complete a questionnaire and have their medical records reviewed on study.

Treatment:

Other: Non-Interventional Study