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Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, X-rays, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients undergo blood sample collection, glucose testing, dual-energy x-ray absorptiometry (DEXA) scan to measure body composition, complete a questionnaire and have their medical records reviewed on study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how hormone treatments for breast cancer affect blood sugar control and diabetes risk. It includes women after menopause who are starting or recently started certain hormone treatments, as well as healthy women after menopause.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women after menopause, defined as no periods for 12 months or surgery to remove both ovaries and fallopian tubes.
  • For the treatment groups: breast cancer that responds to hormones, DCIS (abnormal cells inside breast milk ducts), or another breast condition with a high cancer risk.
  • 25 women who plan to start aromatase inhibitors (a hormone treatment) or started them within the past 6 months, after a breast clinic and cancer center visit.
  • 25 women who will start tamoxifen (another hormone treatment), for comparison.
  • 25 healthy women after menopause.

Who can't join

  • Already diagnosed with diabetes.
  • Taking medicines that could affect blood sugar control.
  • A screening blood sugar level after fasting of 126 mg/dL or higher, or an HbA1c of 6.5% or higher. HbA1c measures average blood sugar over time.
  • Past surgery on the upper digestive tract that changes how the stomach empties or reduces nutrient absorption, such as weight-loss surgery or fundoplication (surgery for acid reflux).

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

MN