Exercise and Intranasal Insulin in Type 2 Diabetes

Conditions

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

Eligibility Criteria

Sex

ALL

Age

55 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Intranasal Insulin — DRUG
  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 — DRUG
  Saline will be administered twice daily (20 seconds in each nostril) using the Kurve Technology intranasal insulin device.
• High Intensity Exercise — BEHAVIORAL
  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.

Study Details

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.

Key Dates

Start date

Aug 3, 2026

Status verified

Jun 2026

Primary completion

May 18, 2029

Completion

May 31, 2029

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: HiEx with Intranasal Placebo
• Active Comparator: HiEx with Intranasal Insulin

Primary Outcome Measure

Cerebrovascular Insulin Sensitivity [ Time Frame: Change from baseline to the end of the intervention at 16 weeks ]

Central Contacts

• Steven K Malin, PhD
  848-932-7540
  [email protected]
• Emily M Heiston, PhD
  848-932-7540
  [email protected]

Locations (4)

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