Insulin Resistance Clinical Trial
— METBCOfficial title:
Metformin Use to Reduce Disparities in Newly Diagnosed Breast Cancer Response to Neoadjuvant Treatment
Verified date | July 2023 |
Source | Woman's |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Breast cancer is one of the most common malignancies in women globally, with ~1.4 million new cases diagnosed annually Breast cancer is one of the leading causes of cancer-related morbidity and mortality among women worldwide. While diabetes/insulin-resistance and breast cancer are distinct diseases, insulin-signaling plays a central role in both illnesses. Insulin activates key cancer processes including epithelial-mesenchymal transition (EMT), tissue inflammation, motility, and angiogenesis. There are key opportunities to impact and prevent hyperinsulinemia during breast cancer prevention, surgical assessment, and chemotherapy. Given the high prevalence of undiagnosed pre-diabetes and diabetes in the United States and worldwide, preoperative screening to identify such patients prior to surgical intervention is warranted. While it is not standard of care to test for insulin-resistance during the course of breast cancer screening and treatment, it is standard of care to screen and test high risk women for insulin-resistance as part of whole woman care. Given the important role insulin signaling plays in driving signaling pathways that promote aggressive cancer biology, more attention should be paid by cancer physicians to screening and treating insulin resistance. Several studies have reinforced a link between breast cancer risk and diabetes. Moreover, metformin significantly reduces breast cancer risk, compared to patients who are not using metformin and is independent of diabetes status. As metformin has an association with decreased breast cancer recurrence, as well as potentially improved survival, disparities in insulin resistance between black and white women with breast cancer is important to investigate. It is hypothesized that metformin decreases the development of resistance in breast cancer cells, thereby allowing current chemotherapy agents to work synergistically with metformin. Our objective is to elucidate whether or not metformin is efficacious in improving insulin resistance in black and white women with breast cancer and if racial disparities in breast cancer prognosis can be partially explained by differences in pre-diagnosis insulin resistance which are improved with metformin therapy.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2022 |
Est. primary completion date | September 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility | 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]. |
Country | Name | City | State |
---|---|---|---|
United States | Woman's Hospital | Baton Rouge | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Woman's | American Cancer Society, Inc., Our Lady of the Lake Regional Medical Center, Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Recurrence rate of breast cancer | follow-up for recurrence of cancer | 3 years | |
Primary | Tumor progression | breast cancer response rate to metformin treatment prior to surgery pathologic response to treatment at surgery will be defined by the following categories: 0-no response; 1-partial response; and 2-complete response with metformin therapy | 6 to 12 months | |
Secondary | Fasting glucose levels | Fasting glucose at start of OGTT | 6 to 12 months | |
Secondary | Mean glucose stimulated levels after an OGTT | Mean blood glucose (MBG) concentrations will be calculated by summing glucose values obtained at 0, 30, 60, and 120 minutes during the OGTT and dividing by 4. | 6 to 12 months | |
Secondary | Homeostatic Model Assessment of Insulin Resistance Index (HOMA-IR) | HOMA will be calculated using the equation: fasting insulin concentration (µIU/mL) × fasting glucose concentration (mmol/L) 22.5 | 6 to 12 months | |
Secondary | Matsuda's insulin sensitivity index (SIOGTT) | SIOGTT will be calculated according to the formula:
10,000/v [fasting glucose (mg/dL) ×fasting insulin (µU/L) × [MPG × MSI during OGTT], where MPG (mg/dL) is mean plasma glucose OGTT, and MSI (µIU/mL) is mean serum insulin during OGTT |
6 to 12 months | |
Secondary | Early pancreatic ß-cell response | IGI/HOMA-IR estimated as the insulinogenic index (IGI) derived from the ratio of the increment of insulin to that of glucose 30 minutes after a glucose load (insulin 30 min - insulin 0 min/glucose 30 min - glucose 0 min) corrected for by the relative level of insulin resistance | 6 to 12 months | |
Secondary | Insulin secretion-sensitivity index (ISSI) | IS-SI derived by applying the concept of the disposition index to measurements obtained during the 2-h OGTT and calculated as the index of insulin secretion factored by insulin resistance (?INS/?PG 30 x Matsuda SIOGTT) during the OGTT | 6 to 12 months |
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