Human Models of Selective Insulin Resistance: Alpelisib, Part I (Diabetes)
Sponsor: |
Dr. Joshua Cook |
Enrolling: |
Male and Female Patients |
Clinic Visits: |
3 |
IRB Number: |
AAAU9636 |
U.S. Govt. ID: |
NCT06354088 |
Contact: |
Zachary Sone: / zds2120@cumc.columbia.edu |
We are recruiting volunteers, aged 18-70, for a research study on the buildup of excessive liver fat ("fatty liver disease") in people with or at risk for type 2 diabetes because their bodies are resistant to the actions of the blood sugar-lowering hormone, insulin. To do this, we seek to temporarily induce or accentuate insulin resistance in 16 volunteers using a medication called alpelisib (brand name: Piqray), which is a drug (pill) used to treat certain breast cancers. Were looking for people with body mass indices (BMI) in the lean, overweight, or obese range (18.0-45.0 kg/m2) and do not have a diagnosis of diabetes, although prediabetes is okay for those in the overweight and obese ranges. Participants will stay overnight in the hospital twice, for up to 30 hours, 2-8 weeks apart. Participants will, in random order, take a single dose of either alpelisib at one of the visits and a single dose of placebo at the other. In both cases, they will then receive intravenous (into the vein) infusions of non-radioactive tracer molecules that allow us to measure how the liver is producing glucose (sugar) and certain fats. Eligible participants will receive compensation for their participation, including a stipend (salary) of up to $700 and reimbursement for travel expenses.
Investigator
Joshua Cook, MD, PhD
Is your body mass index between 18-40 (lean, overweight, or obese range)? |
Yes |
No |
Have you ever been diagnosed with diabetes? |
Yes |
No |
Will you be able to attend two 30-hour inpatient study visits, separated by 2-8 weeks? |
Yes |
No |
Are you okay with receiving medications through veins and having your blood drawn? |
Yes |
No |