Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk
ConditionHER2-Positive Breast Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorMayo Clinic
About this trial
This study assesses the effect of hormone directed treatment for breast cancer on glucose metabolism.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Non-Interventional Study
Other interventionNon-Interventional Study
Treatment groups
81 Participants
are divided into 1 treatment groupGroup A: Observational1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline; up to 1 year2
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.
Time frame
Baseline; up to 1 year3
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.
Time frame
Baseline; up to 1 yearSponsors and contacts
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Source ClinicalTrials.gov