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Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise

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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

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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