FEASibility testing a randomized controlled trial of an exercise program to improve cognition for T2DM patients (the FEAST trial): A study protocol.

While cognitive dysfunction is an important concern in persons with type 2 diabetes mellitus (T2DM), it has received little attention in the T2DM literature. Although it often remains unrecognized, cognitive dysfunction associated with T2DM can lead to severe consequences. Prior research studies have consistently shown that aerobic exercise enhances cognitive function among healthy subjects. However, very few studies have examined the effects of aerobic exercise on cognitive function in persons with T2DM. In addition, one important single-nucleotide polymorphism that influences cognition in humans is the brain-derived neurotrophic factor (BDNF) Val66Met variant. Despite strong evidence suggesting aerobic exercise has a beneficial effect on cognitive function, there is significant variability in individual response to exercise programs on cognitive outcomes among Val/Val versus Met carriers. However, the evidence on how the BDNF Val66Met variant influences cognitive outcomes following an aerobic exercise intervention among individuals with T2DM is currently lacking. Therefore, the purpose of this randomized controlled trial is to pilot-test a 3-month supervised exercise program to improve plasma BDNF levels and cognition, overall and according to genotypes of the BDNF Val66Met variant. A total of 81 patients with T2DM will be randomly assigned to either aerobic exercise group (n = 54) or attention control group (n = 27) for 3 months. Outcomes of interest include postintervention changes in plasma BDNF levels, fasting blood glucose, hemoglobin A1c, body mass index, executive function, memory, and processing speed. This study will provide further evidence on use of exercise as a non-pharmaceutical, low-cost intervention to improve cognition in this population.