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
Qualifiers
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 design
Treatments tested in this trial
- Non-Interventional Study
Treatment groups
66 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov