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Trial Title:
Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk
NCT ID:
NCT06557057
Condition:
HER2-Positive Breast Carcinoma
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Non-Interventional Study
Description:
Non-Interventional Study
Arm group label:
Observational
Summary:
This study assesses the effect of hormone directed treatment for breast cancer on glucose
metabolism.
Detailed description:
PRIMARY OBJECTIVE:
I. Assess the impact of endocrine adjuvant therapy with aromatase inhibitors in women
with hormone receptor positive breast cancer, 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, DEXA scan to measure body
composition, complete a questionnaire and have their medical records reviewed on study.
Criteria for eligibility:
Study pop:
Post-menopausal women with hormone receptor positive breast cancer who are planning to
start or within 6 months of starting treatment with an aromatase inhibitor or tamoxifen
and healthy post-menopausal women.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Post-menopausal women with hormone receptor positive breast cancer. 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
Gender:
Female
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Kalpana Muthusamy, MBBS, MD
Start date:
November 16, 2023
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06557057
https://www.mayo.edu/research/clinical-trials
