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Exercise and Intranasal Insulin in Type 2 Diabetes
Sponsor: Rutgers, The State University of New Jersey
Summary
About 6.5 million adults in the United States who are 65 or older have dementia. While the exact cause of dementia is not known, it may be due to changes in the brain. Further, risk may be higher when the brain does not respond to insulin. Indeed, brain insulin resistance has emerged as a pathologic factor affecting memory, executive function as well as systemic glucose control. Regular aerobic exercise may help reduce the risk of dementia by increased blood flow to the brain and help the brain respond better to insulin. In addition, giving insulin through a nose spray (called intranasal insulin) may also help with thinking and memory. However, it is unknown if using both exercise and intranasal insulin is best for the brain.
Official title: Effects of Intranasal Insulin Plus Exercise Training on Brain Blood Flow, Neuronal Insulin Signaling, and Cognition in Adults With Type 2 Diabetes
Key Details
Gender
All
Age Range
55 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-08-03
Completion Date
2029-05-31
Last Updated
2026-06-30
Healthy Volunteers
No
Interventions
Intranasal Insulin
Dosage will be 20 IU of INI twice per day (40 IU in total/day). The study will use the Kurve Technology intranasal device, which delivers a 20 second stream of insulin through a nose piece into a nostril, after which the device switches off. The process will then be repeated in the other nostril.
Intranasal Placebo
Saline will be administered twice daily (20 seconds in each nostril) using the Kurve Technology intranasal insulin device.
High Intensity Exercise
High intensity exercise will consist of 16 weeks of walking at \~85% of each participant's predetermined VO2max and monitored via heart rate. Supervised exercised will occur on a treadmill 3d/wk. The duration of each exercise session will be adjusted based on fitness level so that \~300 kcal will be expended per training session during weeks 1-2, 350 kcal per training session during weeks 3-4, and 400 kcal per training session during weeks 5-16. This usually equals \~60 minutes per session but can vary from person to person. Each session will start with a 5-minute warm-up and end with a 5-minute cool down. During each exercise session, individuals will wear a heart rate monitor rating of perceived exertion will be recorded.
Locations (4)
Robert Wood Johnson University Hospital Clinical Research Center
New Brunswick, New Jersey, United States
Institute for Food, Nutrition, and Health
New Brunswick, New Jersey, United States
Rutgers University Loree Gymnasium
New Brunswick, New Jersey, United States
Center for Advanced Human Brain Imaging Research
Piscataway, New Jersey, United States