Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-16

Study Completion Date

2026-12-01

Brief Summary

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

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Detailed Description

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PRIMARY OBJECTIVE:

I. Assess the impact of endocrine adjuvant therapy with aromatase inhibitors in women with hormone receptor positive breast cancer or ductal carcinoma in situ (DCIS) 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.

Conditions

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HER2-Positive Breast Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational

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

Non-Interventional Study

Intervention Type OTHER

Non-Interventional Study

Interventions

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Non-Interventional Study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Post-menopausal women with hormone receptor positive breast cancer or ductal carcinoma in situ (DCIS). 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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes