Clinical trial · Observational
Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk
NCT06557057CI-TRIAL-00125244recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study assesses the effect of hormone directed treatment for breast cancer on glucose metabolism.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-Positive Breast Carcinoma | HER2-Positive Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Interventional Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational
- description
- Patients undergo blood sample collection, glucose testing, DEXA scan to measure body composition, complete a questionnaire and have their medical records reviewed on study.
- interventionNames
- Other: Non-Interventional Study
Primary outcomes (3)
- measure
- Disposition Index (DI)
- timeFrame
- Baseline; up to 1 year
- description
- 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.
- measure
- Glucose homeostasis - tamoxifen compared to no treatment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.