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NCT Number: NCT06557057

Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk

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

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Key information

Conditions

HER2-Positive Breast Carcinoma

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Kalpana Muthusamy, MBBS, MD

PRINCIPAL_INVESTIGATOR

About this study

PRIMARY OBJECTIVE:

I. Assess the impact of endocrine adjuvant therapy with aromatase inhibitors in women with hormone receptor positive breast cancer, ductal carcinoma in situ (cancer, DCIS ), or women with other high risk breast conditions, 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, dual-energy x-ray absorptiometry (DEXA) scan to measure body composition, complete a questionnaire and have their medical records reviewed on study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-Interventional Study

Primary outcomes

  1. Disposition Index (DI)

    Time frame: Baseline; up to 1 year

    Will be calculated as the product of beta cell responsivity and Si (insulin action). DI of women with hormone receptor positive breast cancer or DCIS 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.

  2. Glucose homeostasis - tamoxifen compared to no treatment

    Time frame: 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 or DCIS 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.

  3. Glucose homeostasis - aromatase inhibitor compared to tamoxifen

    Time frame: 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 or DCIS 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 16, 2024
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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