Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men Initiating Androgen Deprivation Therapy For Prostate Cancer
Androgen deprivation therapy (ADT) is the standard treatment for advanced prostate cancer.
While a very effective anti-cancer treatment, ADT is associated with significant toxicity
including but not limited to major metabolic disturbances including impaired glucose
tolerance, insulin resistance, and weight gain. We hypothesize that limiting carbohydrates
within the diet will prevent or at least minimize these consequences.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
The primary end-point will be differences in insulin sensitivity between the arms
Stephen J Freedland, MD
United States: Institutional Review Board
|Duke University Medical Center||Durham, North Carolina 27710|
|University of California, Los Angeles||Los Angeles, California|
|Greater Los Angeles VA Medical Center||Los Angeles, California 90073|