Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT04741204
Eligibility Criteria:
Inclusion Criteria:
* Non-Hispanic white or black females
* Age \> = 18 years
* English speaking
* Newly diagnosed breast cancer
* BMI \> = 25 (must be overweight)
* Insulin-resistant (as determined by 2 hour 75 gm oral glucose tolerance test (OGTT)). Concentrations and trajectories of insulin and glucose at 0, 30, 60, and 120 min during an oral glucose tolerance test will undergo mathematical modeling. The numbers for defining insulin resistance have been established in the Woman's Laboratory and are interpreted by the pathologists.
Exclusion Criteria:
* Metastatic Disease
* Current diagnosis of Diabetes or diagnosed with diabetes (as determined by HbA1C\> 6.5)
* Having surgery prior to chemotherapy
* Medical conditions for which metformin is contraindicated (gastrointestinal and renal failure),
* Abnormal CBC (defined by a baseline platelet count of less than 130 and a baseline absolute neutrophil count of less than 1000). In addition, baseline hemoglobin of less than 10, if there is no evidence of a concurrent nutritional deficiency (like iron). \[Patients simply needing something like iron to correct the anemia will not be excluded\].
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04741204
Study Brief:
Protocol Section:
NCT04741204