Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk
Recruiting · NCT06557057 · Observational (researchers observe without assigning treatment) · Lead sponsor: Mayo Clinic
View the official record on ClinicalTrials.gov →Interventions studied
Non-Interventional Study
What this trial is about
This study assesses the effect of hormone directed treatment for breast cancer on glucose metabolism.
Who can take part
Age range
No age limits stated
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 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
Where it is running
1 location listed across 1 US state.
- Mayo Clinic in Rochester - Rochester, Minnesota, United States