Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk

Recruiting

• Conditions: HER2-Positive Breast Carcinoma
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06557057
• Lead Sponsor: Mayo Clinic

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, 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 Timeline

• Study Start: 2023-11-16
• Status Verified: 2024-08
• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-13
• Last Update Submitted: 2024-08-13
• Study First Posted: 2024-08-16
• Last Update Posted: 2024-08-16
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 75

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.

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional 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.

Primary Outcome Measures

Name	Time	Method
DI (disposition index)	Baseline; up to 1 year	Will be calculated as the product of beta cell responsivity and Si (insulin action) Si. DI of women with hormone receptor positive breast cancer treated with aromatase inhibitors will be compared to DI of healthy post menopausal women. Participants will undergo a history, physical examination, and a blood collection for fasting glucose, and Hemoglobin A1C (HbA1c) at baseline and one year later. Participants will be contacted at 3 and 6 months by phone to confirm continued use of the endocrine therapy that was initiated by the clinical team.
Glucose homeostasis - tamoxifen compared to no treatment	Baseline; up to 1 year	Glucose homeostasis is the process by which the body regulates blood glucose levels, also known as blood sugar, within a narrow range. Glucose homeostasis of women with hormone receptor positive breast cancer treated with tamoxifen will be compared to glucose homeostasis of women without treatment. Participants will undergo a history, physical examination, and a blood collection for fasting glucose, and Hemoglobin A1C (HbA1c) at baseline and one year later. Participants will be contacted at 3 and 6 months by phone to confirm continued use of the endocrine therapy that was initiated by the clinical team.
Glucose homeostasis - aromatase inhibitor compared to tamoxifen	Baseline; up to 1 year	Glucose homeostasis is the process by which the body regulates blood glucose levels, also known as blood sugar, within a narrow range. Glucose homeostasis of women with hormone receptor positive breast cancer treated with aromatase inhibitors will be compared to glucose homeostasis of women treated with tamoxifen. Participants will undergo a history, physical examination, and a blood collection for fasting glucose, and Hemoglobin A1C (HbA1c) at baseline and one year later. Participants will be contacted at 3 and 6 months by phone to confirm continued use of the endocrine therapy that was initiated by the clinical team.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States