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Observational Study on Aromatase Inhibitors and Glucose Homeostasis

This study is looking at how hormone treatments for breast cancer affect your body's ability to manage blood sugar (glucose homeostasis). Researchers want to see if aromatase inhibitors, a type of hormone therapy, impact your risk of developing diabetes. They will compare women taking aromatase inhibitors to healthy post-menopausal women and women taking tamoxifen, another breast cancer treatment. You might be able to join if you are a post-menopausal woman with hormone receptor positive breast cancer, ductal carcinoma in situ (DCIS), or other high-risk breast conditions. The study aims to understand how these treatments affect your blood sugar levels over about one year. The study is currently recruiting 66 participants.

Study design
This is an observational study involving 66 post-menopausal women.
What's involved
You would provide blood samples, undergo glucose testing, have a DEXA scan for body composition, complete a questionnaire, and have your medical records reviewed.
Compensation
Not stated in the trial record.
Follow-up
Your glucose homeostasis will be measured at baseline and up to one year.

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NCT06557057

Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk

Recruiting
Not specifiedAll AgesObservational
Mayo Clinic
~66 participants
Updated 2026-03-31 on ClinicalTrials.gov
What's tested:Non-Interventional Study

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disposition Index (DI)
Measured over Baseline; up to 1 year
+2 more outcomes measured

Conditions

HER2-Positive Breast Carcinoma

Explore related trials

Breast CarcinomaBreast Ductal Carcinoma In SituHormone Receptor

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Kalpana Muthusamy, MBBS, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Disposition Index (DI)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.

  • Glucose homeostasis - tamoxifen compared to no treatmentBaseline; 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.

  • Glucose homeostasis - aromatase inhibitor compared to tamoxifenBaseline; 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.