60 Participants NeededMy employer runs this trial

Intranasal Insulin + Exercise for Type 2 Diabetes

Recruiting at 3 trial locations
SK
EM
Overseen ByEmily M Heiston, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Rutgers, The State University of New Jersey
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

SK

Steven K Malin, PhD

Principal Investigator

Rutgers University - New Brunswick

Are You a Good Fit for This Trial?

This trial is for adults with type 2 diabetes and insulin resistance. Participants should not have conditions that would prevent them from safely exercising or using a nasal spray, and must be able to take part in memory and thinking tests.

Inclusion Criteria

MOCA ≥26
I am between 55 and 80 years old.
Not currently engaged in <90 min/wk of exercise
See 4 more

Exclusion Criteria

I do not have uncontrolled high blood pressure.
History of significant metabolic, cardiac, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, or endocrine disease or cancer impacting outcome measures or safety
Claustrophobia or significant anxiety in closed places
See 19 more

What Are the Treatments Tested in This Trial?

Interventions

  • High Intensity Exercise
  • Intranasal Insulin
  • Intranasal Placebo

Trial Overview

The study is testing whether high-intensity exercise, intranasal insulin (insulin given as a nose spray), or both together can improve brain function, blood flow in the brain, and how the body handles sugar compared to a placebo nasal spray.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: HiEx with Intranasal InsulinActive Control2 Interventions
Group II: HiEx with Intranasal PlaceboPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials
471
Recruited
81,700+

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

Collaborator

Trials
2,513
Recruited
4,366,000+