Exercise and Intranasal Insulin in Type 2 Diabetes

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.

Conditions

• Type 2 Diabetes
• Insulin Sensitivity/Resistance
• Cognition
• Brain Blood Flow

Interventions

DRUG

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.

DRUG

Intranasal Placebo

Saline will be administered twice daily (20 seconds in each nostril) using the Kurve Technology intranasal insulin device.

BEHAVIORAL

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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Rutgers, The State University of New Jersey

  lead OTHER

Principal Investigators

• Steven K Malin, PhD · Rutgers University - New Brunswick

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-03

Primary Completion

2029-05-18

Completion

2029-05-31

FDA Drug

Yes

Countries

• United States

Study Locations