Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise

Michigan State University

Status and phase: Completed; Phase 2

Conditions: Insulin; Exercise

Treatments: Drug: Placebo into the intranasal mucosa; Drug: 20 IU NovoLog Insulin aspart into the intranasal mucosa; Drug: 80 IU NovoLog Insulin aspart into the intranasal mucosa; Drug: 40 IU NovoLog Insulin aspart into the intranasal mucosa; Drug: 60 IU NovoLog Insulin aspart into the intranasal mucosa; Drug: 120 IU NovoLog Insulin aspart into the intranasal mucosa; Drug: 100 IU NovoLog Insulin aspart into the intranasal mucosa

Study type: Interventional

Funder types: Other

Identifiers

NCT04292535

STUDY00000804

Details and patient eligibility

About

To determine if physical activity engagement alters the dose-response profile and safety of administration of insulin into the intranasal mucosa.

Full description

Using a randomized placebo controlled double-blind pre-posttest design, participants will be randomly assigned to receive a dose of either 0, 20, 40, 60, 80, 100, or 120 IU of NovoLog insulin aspart prior to being randomized into participating in a 20 minute session of either moderate-intensity aerobic exercise or a passive control condition. The efficacy of the intranasal insulin for inducing alterations in cognition will be assessed using both behavioral and neuroelectric measures. The safety of the protocol will be assessed using a symptom questionnaire assessing common symptoms of altered blood glucose and common side effects of intranasal insulin.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Participants must be over the age of 18..
2. Participants must have normal or corrected-to-normal vision in order to complete the cognitive task.

Exclusion criteria

1. Lack of consent.
2. Presence of any major neurological health issues, brain trauma, or concussion with loss of consciousness assessed through a health history and demographics questionnaire.
3. Type I or Type II Diabetes
4. Self-reported pregnancy
5. Currently has any type of inflammation or blockage of the nasal passageways (i.e. allergies or a cold affecting the sinuses).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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116 participants in 2 patient groups

Passive Control

Active Comparator group

Description:

20 minute sedentary control period during which participants watched an emotionally neutral video.

Treatment:

Drug: 100 IU NovoLog Insulin aspart into the intranasal mucosa

Drug: 120 IU NovoLog Insulin aspart into the intranasal mucosa

Drug: 60 IU NovoLog Insulin aspart into the intranasal mucosa

Drug: 40 IU NovoLog Insulin aspart into the intranasal mucosa

Drug: 80 IU NovoLog Insulin aspart into the intranasal mucosa

Drug: 20 IU NovoLog Insulin aspart into the intranasal mucosa

Drug: Placebo into the intranasal mucosa

Acute Exercise

Experimental group

Description:

20 minute physical activity period during which participants exercised on a treadmill at an intensity corresponding to 60-65% of maximum heart rate while watching an emotionally neutral video.

Treatment:

Drug: 100 IU NovoLog Insulin aspart into the intranasal mucosa

Drug: 120 IU NovoLog Insulin aspart into the intranasal mucosa

Drug: 60 IU NovoLog Insulin aspart into the intranasal mucosa

Drug: 40 IU NovoLog Insulin aspart into the intranasal mucosa

Drug: 80 IU NovoLog Insulin aspart into the intranasal mucosa

Drug: 20 IU NovoLog Insulin aspart into the intranasal mucosa

Drug: Placebo into the intranasal mucosa