Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk

NCT06557057 | Recruiting

• 1 other identifier: 23-005595
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HER2-Positive Breast Carcinoma

Outcome Measures

Primary Outcomes (3)

• Disposition Index (DI)

  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.

  Baseline; up to 1 year

• Glucose homeostasis - tamoxifen compared to no treatment

  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.

  Baseline; up to 1 year

• Glucose homeostasis - aromatase inhibitor compared to tamoxifen

  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.

  Baseline; up to 1 year

Study Arms (1)

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.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-Interventional Study

Observational

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Post-menopausal women with hormone receptor positive breast cancer, DCIS, or other high risk breast conditions who are planning to start or within 6 months of starting treatment with an aromatase inhibitor or tamoxifen and healthy post-menopausal women.

You may qualify if:

• 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.
• 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.
• women who will be starting Tamoxifen (comparative group)
• healthy post menopausal women will also be recruited.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples retained for future research with permission of participant

Study Officials

• Kalpana Muthusamy, MBBS, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 16, 2024
• Study Start: November 16, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

US (1)