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NCT06557057 | RECRUITING | HER2-Positive Breast Carcinoma

Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk
Sponsor:

Mayo Clinic

Brief Summary:

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

Condition or disease

HER2-Positive Breast Carcinoma

Intervention/treatment

Non-Interventional Study

Detailed 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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 75 participants
Official Title : Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk
Actual Study Start Date : 2023-11-16
Estimated Primary Completion Date : 2025-12-01
Estimated Study Completion Date : 2025-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
Criteria
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
Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk

Location Details

NCT06557057

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How to Participate

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Locations

RECRUITING

United States, Minnesota

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905